GI Oncology

Gastroenterology

January 2024

Hirano I, et al; ASCENT WORKING GROUP. Ascending to New Heights for Novel Therapeutics for Eosinophilic Esophagitis. Gastroenterology. 2024 Jan;166(1):1-10. doi: 10.1053/j.gastro.2023.09.004. Epub 2023 Sep 9. PMID: 37690772; PMCID: PMC10872872.



Åkerström JH, et al. Antireflux Surgery Versus Antireflux Medication and Risk of Esophageal Adenocarcinoma in Patients With Barrett’s Esophagus. Gastroenterology. 2024 Jan;166(1):132-138.e3. doi: 10.1053/j.gastro.2023.08.050. Epub 2023 Sep 9. PMID: 37690771.



Barnes EL, et al; AGA Clinical Guidelines Committee. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. doi: 10.1053/j.gastro.2023.10.015. PMID: 38128971.

February 2024

Yoo HW, et al. Helicobacter pylori Treatment and Gastric Cancer Risk After Endoscopic Resection of Dysplasia: A Nationwide Cohort Study. Gastroenterology. 2024 Feb;166(2):313-322.e3. doi: 10.1053/j.gastro.2023.10.013. Epub 2023 Oct 18. PMID: 37863270.



Yang J, et al. High Soluble Fiber Promotes Colorectal Tumorigenesis Through Modulating Gut Microbiota and Metabolites in Mice. Gastroenterology. 2024 Feb;166(2):323-337.e7. doi: 10.1053/j.gastro.2023.10.012. Epub 2023 Oct 18. PMID: 37858797.



Young E, et al. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14. PMID: 37839498.
 

Clinical Gastroenterology and Hepatology

January 2024

Overbeek KA, et al; Dutch Familial Pancreatic Cancer Surveillance Study work group. Intraductal Papillary Mucinous Neoplasms in High-Risk Individuals: Incidence, Growth Rate, and Malignancy Risk. Clin Gastroenterol Hepatol. 2024 Jan;22(1):62-71.e7. doi: 10.1016/j.cgh.2023.03.035. Epub 2023 Apr 7. PMID: 37031711.

Reddy CA, et al. Achalasia is Strongly Associated With Eosinophilic Esophagitis and Other Allergic Disorders. Clin Gastroenterol Hepatol. 2024 Jan;22(1):34-41.e2. doi: 10.1016/j.cgh.2023.06.013. Epub 2023 Jun 28. PMID: 37391057; PMCID: PMC10753026.

Thiruvengadam NR, et al. The Clinical Impact and Cost-Effectiveness of Surveillance of Incidentally Detected Gastric Intestinal Metaplasia: A Microsimulation Analysis. Clin Gastroenterol Hepatol. 2024 Jan;22(1):51-61. doi: 10.1016/j.cgh.2023.05.028. Epub 2023 Jun 9. Erratum in: Clin Gastroenterol Hepatol. 2024 Jan 19;: PMID: 37302442.

February 2024

Goodoory VC, et al. Systematic Review and Meta-analysis: Efficacy of Mesalamine in Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):243-251.e5. doi: 10.1016/j.cgh.2023.02.014. Epub 2023 Feb 27. PMID: 36858143.

Brenner DM, et al. Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):222-234. doi: 10.1016/j.cgh.2023.09.013. Epub 2023 Sep 22. PMID: 37743035.
 

Techniques and Innovations in Gastrointestinal Endoscopy

January 2024

Ramirez PR, et al. Gaps and Improvement Opportunities in Post-Colonoscopy Communication. Tech Innov Gastrointest Endosc. 2024 Jan;26(1):90-92. doi: 10.1016/j.tige.2023.10.001. Epub 2023 Oct 22.

Gonzaga ER, et al. Gastric Peroral Endoscopic Myotomy (G-POEM) for the Management of Gastroparesis. Tech Innov Gastrointest Endosc. 2024 Jan; 26(1): 46-55. doi: 10.1016/j.tige.2023.09.002. Epub 2023 Oct 13.



Wang D, et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2024 Jan;26(1): 30-37. doi: 10.1016/j.tige.2023.10.003. Epub 2023 Nov 8.
 

Gastro Hep Advances

January 2024

Adeniran E, et al. Intense and Sustained Alcohol Consumption Associated With Acute Pancreatitis Warrants Early Intervention. Gastro Hep Advances. 2024 Jan;3(1):61-63. doi: 10.1016/j.gastha.2023.08.017. Epub 2023 Sep 2.

Alkhouri N, et al. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Advances. 2024 Jan;3(1): 9-16. doi: 10.1016/j.gastha.2023.08.019. Epub 2023 Oct 1.

Gastroenterology

January 2024

Hirano I, et al; ASCENT WORKING GROUP. Ascending to New Heights for Novel Therapeutics for Eosinophilic Esophagitis. Gastroenterology. 2024 Jan;166(1):1-10. doi: 10.1053/j.gastro.2023.09.004. Epub 2023 Sep 9. PMID: 37690772; PMCID: PMC10872872.



Åkerström JH, et al. Antireflux Surgery Versus Antireflux Medication and Risk of Esophageal Adenocarcinoma in Patients With Barrett’s Esophagus. Gastroenterology. 2024 Jan;166(1):132-138.e3. doi: 10.1053/j.gastro.2023.08.050. Epub 2023 Sep 9. PMID: 37690771.



Barnes EL, et al; AGA Clinical Guidelines Committee. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. doi: 10.1053/j.gastro.2023.10.015. PMID: 38128971.

February 2024

Yoo HW, et al. Helicobacter pylori Treatment and Gastric Cancer Risk After Endoscopic Resection of Dysplasia: A Nationwide Cohort Study. Gastroenterology. 2024 Feb;166(2):313-322.e3. doi: 10.1053/j.gastro.2023.10.013. Epub 2023 Oct 18. PMID: 37863270.



Yang J, et al. High Soluble Fiber Promotes Colorectal Tumorigenesis Through Modulating Gut Microbiota and Metabolites in Mice. Gastroenterology. 2024 Feb;166(2):323-337.e7. doi: 10.1053/j.gastro.2023.10.012. Epub 2023 Oct 18. PMID: 37858797.



Young E, et al. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14. PMID: 37839498.
 

Clinical Gastroenterology and Hepatology

January 2024

Overbeek KA, et al; Dutch Familial Pancreatic Cancer Surveillance Study work group. Intraductal Papillary Mucinous Neoplasms in High-Risk Individuals: Incidence, Growth Rate, and Malignancy Risk. Clin Gastroenterol Hepatol. 2024 Jan;22(1):62-71.e7. doi: 10.1016/j.cgh.2023.03.035. Epub 2023 Apr 7. PMID: 37031711.

Reddy CA, et al. Achalasia is Strongly Associated With Eosinophilic Esophagitis and Other Allergic Disorders. Clin Gastroenterol Hepatol. 2024 Jan;22(1):34-41.e2. doi: 10.1016/j.cgh.2023.06.013. Epub 2023 Jun 28. PMID: 37391057; PMCID: PMC10753026.

Thiruvengadam NR, et al. The Clinical Impact and Cost-Effectiveness of Surveillance of Incidentally Detected Gastric Intestinal Metaplasia: A Microsimulation Analysis. Clin Gastroenterol Hepatol. 2024 Jan;22(1):51-61. doi: 10.1016/j.cgh.2023.05.028. Epub 2023 Jun 9. Erratum in: Clin Gastroenterol Hepatol. 2024 Jan 19;: PMID: 37302442.

February 2024

Goodoory VC, et al. Systematic Review and Meta-analysis: Efficacy of Mesalamine in Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):243-251.e5. doi: 10.1016/j.cgh.2023.02.014. Epub 2023 Feb 27. PMID: 36858143.

Brenner DM, et al. Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):222-234. doi: 10.1016/j.cgh.2023.09.013. Epub 2023 Sep 22. PMID: 37743035.
 

Techniques and Innovations in Gastrointestinal Endoscopy

January 2024

Ramirez PR, et al. Gaps and Improvement Opportunities in Post-Colonoscopy Communication. Tech Innov Gastrointest Endosc. 2024 Jan;26(1):90-92. doi: 10.1016/j.tige.2023.10.001. Epub 2023 Oct 22.

Gonzaga ER, et al. Gastric Peroral Endoscopic Myotomy (G-POEM) for the Management of Gastroparesis. Tech Innov Gastrointest Endosc. 2024 Jan; 26(1): 46-55. doi: 10.1016/j.tige.2023.09.002. Epub 2023 Oct 13.



Wang D, et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2024 Jan;26(1): 30-37. doi: 10.1016/j.tige.2023.10.003. Epub 2023 Nov 8.
 

Gastro Hep Advances

January 2024

Adeniran E, et al. Intense and Sustained Alcohol Consumption Associated With Acute Pancreatitis Warrants Early Intervention. Gastro Hep Advances. 2024 Jan;3(1):61-63. doi: 10.1016/j.gastha.2023.08.017. Epub 2023 Sep 2.

Alkhouri N, et al. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Advances. 2024 Jan;3(1): 9-16. doi: 10.1016/j.gastha.2023.08.019. Epub 2023 Oct 1.

Gastroenterology

January 2024

Hirano I, et al; ASCENT WORKING GROUP. Ascending to New Heights for Novel Therapeutics for Eosinophilic Esophagitis. Gastroenterology. 2024 Jan;166(1):1-10. doi: 10.1053/j.gastro.2023.09.004. Epub 2023 Sep 9. PMID: 37690772; PMCID: PMC10872872.



Åkerström JH, et al. Antireflux Surgery Versus Antireflux Medication and Risk of Esophageal Adenocarcinoma in Patients With Barrett’s Esophagus. Gastroenterology. 2024 Jan;166(1):132-138.e3. doi: 10.1053/j.gastro.2023.08.050. Epub 2023 Sep 9. PMID: 37690771.



Barnes EL, et al; AGA Clinical Guidelines Committee. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. doi: 10.1053/j.gastro.2023.10.015. PMID: 38128971.

February 2024

Yoo HW, et al. Helicobacter pylori Treatment and Gastric Cancer Risk After Endoscopic Resection of Dysplasia: A Nationwide Cohort Study. Gastroenterology. 2024 Feb;166(2):313-322.e3. doi: 10.1053/j.gastro.2023.10.013. Epub 2023 Oct 18. PMID: 37863270.



Yang J, et al. High Soluble Fiber Promotes Colorectal Tumorigenesis Through Modulating Gut Microbiota and Metabolites in Mice. Gastroenterology. 2024 Feb;166(2):323-337.e7. doi: 10.1053/j.gastro.2023.10.012. Epub 2023 Oct 18. PMID: 37858797.



Young E, et al. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14. PMID: 37839498.
 

Clinical Gastroenterology and Hepatology

January 2024

Overbeek KA, et al; Dutch Familial Pancreatic Cancer Surveillance Study work group. Intraductal Papillary Mucinous Neoplasms in High-Risk Individuals: Incidence, Growth Rate, and Malignancy Risk. Clin Gastroenterol Hepatol. 2024 Jan;22(1):62-71.e7. doi: 10.1016/j.cgh.2023.03.035. Epub 2023 Apr 7. PMID: 37031711.

Reddy CA, et al. Achalasia is Strongly Associated With Eosinophilic Esophagitis and Other Allergic Disorders. Clin Gastroenterol Hepatol. 2024 Jan;22(1):34-41.e2. doi: 10.1016/j.cgh.2023.06.013. Epub 2023 Jun 28. PMID: 37391057; PMCID: PMC10753026.

Thiruvengadam NR, et al. The Clinical Impact and Cost-Effectiveness of Surveillance of Incidentally Detected Gastric Intestinal Metaplasia: A Microsimulation Analysis. Clin Gastroenterol Hepatol. 2024 Jan;22(1):51-61. doi: 10.1016/j.cgh.2023.05.028. Epub 2023 Jun 9. Erratum in: Clin Gastroenterol Hepatol. 2024 Jan 19;: PMID: 37302442.

February 2024

Goodoory VC, et al. Systematic Review and Meta-analysis: Efficacy of Mesalamine in Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):243-251.e5. doi: 10.1016/j.cgh.2023.02.014. Epub 2023 Feb 27. PMID: 36858143.

Brenner DM, et al. Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):222-234. doi: 10.1016/j.cgh.2023.09.013. Epub 2023 Sep 22. PMID: 37743035.
 

Techniques and Innovations in Gastrointestinal Endoscopy

January 2024

Ramirez PR, et al. Gaps and Improvement Opportunities in Post-Colonoscopy Communication. Tech Innov Gastrointest Endosc. 2024 Jan;26(1):90-92. doi: 10.1016/j.tige.2023.10.001. Epub 2023 Oct 22.

Gonzaga ER, et al. Gastric Peroral Endoscopic Myotomy (G-POEM) for the Management of Gastroparesis. Tech Innov Gastrointest Endosc. 2024 Jan; 26(1): 46-55. doi: 10.1016/j.tige.2023.09.002. Epub 2023 Oct 13.



Wang D, et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2024 Jan;26(1): 30-37. doi: 10.1016/j.tige.2023.10.003. Epub 2023 Nov 8.
 

Gastro Hep Advances

January 2024

Adeniran E, et al. Intense and Sustained Alcohol Consumption Associated With Acute Pancreatitis Warrants Early Intervention. Gastro Hep Advances. 2024 Jan;3(1):61-63. doi: 10.1016/j.gastha.2023.08.017. Epub 2023 Sep 2.

Alkhouri N, et al. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Advances. 2024 Jan;3(1): 9-16. doi: 10.1016/j.gastha.2023.08.019. Epub 2023 Oct 1.

In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years, a cross-sectional study of stage-stratified CRC found.

It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.

Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues in JAMA Network Open.

Montminy_Eric_IL_web.jpg

• Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6).
• Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).
• Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are double those for pancreatic cancer of all stages combined.
• The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).

“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”

His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.
 

Findings From 2000 to 2020

During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).

As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.

Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.
 

Why the CRC Uptick?

“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”

Meyer_Joshua_PA_web.jpg

Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.

More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”

There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”

This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.

In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years, a cross-sectional study of stage-stratified CRC found.

It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.

Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues in JAMA Network Open.

Montminy_Eric_IL_web.jpg

• Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6).
• Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).
• Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are double those for pancreatic cancer of all stages combined.
• The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).

“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”

His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.
 

Findings From 2000 to 2020

During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).

As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.

Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.
 

Why the CRC Uptick?

“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”

Meyer_Joshua_PA_web.jpg

Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.

More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”

There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”

This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.

In the setting of conflicting national screening guidelines, the incidence of distant- and regional-stage colorectal adenocarcinoma (CRC) has been increasing in individuals aged 46-49 years, a cross-sectional study of stage-stratified CRC found.

It is well known that CRC is becoming more prevalent generally in the under 50-year population, but stage-related analyses have not been done.

Staging analysis in this age group is important, however, as an increasing burden of advance-staged disease would provide further evidence for earlier screening initiation, wrote Eric M. Montminy, MD, a gastroenterologist at John H. Stroger Hospital of County Cook, Chicago, Illinois, and colleagues in JAMA Network Open.

Montminy_Eric_IL_web.jpg

• Distant adenocarcinoma IRs increased faster than other stages: annual percentage change (APC), 2.2 (95% CI, 1.8-2.6).
• Regional IRs also significantly increased: APC, 1.3 (95% CI, 0.8-1.7).
• Absolute regional IRs of CRC in the age bracket of 46-49 years are similar to total pancreatic cancer IRs in all ages and all stages combined (13.2 of 100,000) over similar years. When distant IRs for CRC are included with regional IRs, those for IRs for CRC are double those for pancreatic cancer of all stages combined.
• The only decrease was seen in localized IRs: APC, -0.6 (95% CI, -1 to -0.2).

“My best advice for clinicians is to provide the facts from the data to patients so they can make an informed health decision,” Dr. Montminy said. “This includes taking an appropriate personal and family history and having the patient factor this aspect into their decision on when and how they want to perform colon cancer screening.”

His institution adheres to the USPSTF recommendation of initiation of CRC screening at age 45 years.
 

Findings From 2000 to 2020

During 2000-2020 period, 26,887 CRCs were diagnosed in adults aged 46-49 years (54.5% in men).

As of 2020, the localized adenocarcinoma IR decreased to 7.7 of 100,000, but regional adenocarcinoma IR increased to 13.4 of 100,000 and distant adenocarcinoma IR increased to 9.0 of 100,000.

Regional adenocarcinoma IR remained the highest of all stages in 2000-2020. From 2014 to 2020, distant IRs became similar to localized IRs, except in 2017 when distant IRs were significantly higher than localized.
 

Why the CRC Uptick?

“It remains an enigma at this time as to why we’re seeing this shift,” Dr. Montminy said, noting that etiologies from the colonic microbiome to cellphones have been postulated. “To date, no theory has substantially provided causality. But whatever the source is, it is affecting Western countries in unison with data demonstrating a birth cohort effect as well,” he added. “We additionally know, based on the current epidemiologic data, that current screening practices are failing, and a unified discussion must occur in order to prevent young patients from developing advanced colon cancer.”

Meyer_Joshua_PA_web.jpg

Offering his perspective on the findings, Joshua Meyer, MD, vice chair of translational research in the Department of Radiation Oncology at Fox Chase Cancer Center in Philadelphia, said the findings reinforce the practice of offering screening to average-risk individuals starting at age 45 years, the threshold at his institution. “There are previously published data demonstrating an increase in advanced stage at the time of screening initiation, and these data support that,” said Dr. Meyer, who was not involved in the present analysis.

More research needs to be done, he continued, not just on optimal age but also on the effect of multiple other factors impacting risk. “These may include family history and genetic risk as well as the role of blood- and stool-based screening assays in an integrated strategy to screen for colorectal cancer.”

There are multiple screening tests, and while colonoscopy, the gold standard, is very safe, it is not completely without risks, Dr. Meyer added. “And the question of the appropriate allocation of limited societal resources continues to be discussed on a broader level and largely explains the difference between the two guidelines.”

This study received no specific funding. Co-author Jordan J. Karlitz, MD, reported personal fees from GRAIL (senior medical director) and an equity position from Gastro Girl/GI On Demand outside f the submitted work. Dr. Meyer disclosed no conflicts of interest relevant to his comments.

SAN DIEGO — A liquid biopsy assay that combines a microRNA signature and a well-known biomarker for pancreatic cancer has demonstrated an accuracy of 97% for detecting stage I/II pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer.

It is quite encouraging to know we have a blood test that could potentially find this disease early, said Ajay Goel, PhD, a molecular diagnostics specialist at City of Hope in Duarte, California, who presented the findings at the annual meeting of the American Association for Cancer Research (AACR).

Dr. Goel and colleagues developed a signature for pancreatic cancer based on microRNAs identified in the exomes shed from pancreatic cancers and cell-free DNA markers found in the blood of patients with the disease.

Their initial assay tested blood samples for this signature in a training cohort of 252 people in Japan, approximately 60% of whom had pancreatic cancer. The rest were healthy controls. The assay was then tested in validation cohorts of 400 subjects, half with pancreatic cancer and half controls, in China and South Korea.

In both the initial and validation tests, the microRNA assay had an accuracy of about 90% for stage I/II pancreatic cancer, already far better than commercially available assays.

In an additional validation cohort in the United States with 139 patients with pancreatic cancer and 193 controls at six centers across the country, the researchers found that adding carbohydrate antigen 19-9 — a well-known marker of pancreatic cancer — to the assay boosted the test’s accuracy to 97%.

The test performed the same whether the tumor was in the head or tail of the pancreas.

“We are very excited about this data,” said Dr. Goel.

The technology was recently licensed to Pharus Diagnostics for commercial development, which will likely include a prospective screening trial, he told this news organization.

Because pancreatic cancer is fairly uncommon, Dr. Goel did not anticipate the test being used for general screening but rather for screening high-risk patients such as those with newly diagnosed type 2 diabetes, a family history of pancreatic cancer, or predisposing genetic mutations.

“It should be a very inexpensive test; it doesn’t cost us much to do in the lab,” he added.

Study moderator Ryan Corcoran, MD, PhD, a gastrointestinal (GI) oncologist at Massachusetts General Hospital, Boston, saw the potential.

“As a GI oncologist, I know how lethal and hard to treat pancreatic cancer is,” he said. A test that could reliably detect pancreatic cancer early, with an acceptable false-positive rate, would be extremely useful.

“The cure rate is many, many times higher,” if we detect it before it has a chance to spread, he explained.

In the meantime, Dr. Goel said there’s more work to be done.

Almost 4,000 subjects have been enrolled in ongoing validation efforts, and efforts are underway to use the test to screen thousands of banked blood samples from the PLCO, a prospective cancer screening trial in healthy subjects.

The researchers also want to see if the test can distinguish benign pancreatic cysts from ones that turn cancerous.

The idea is to find the earliest possible signs of this disease to see if we can find it not “at the moment of clinical diagnosis, but possibly 6 months, 1 year, 2 years earlier” than with radiologic imaging, Dr. Goel said.

The work was funded by the National Cancer Institute and others. Dr. Goel is a consultant for Pharus Diagnostics and Cellomics. Dr. Corcoran is a consultant for, has grants from, and/or holds stock in numerous companies, including Pfizer, Novartis, Eli Lilly, and Revolution Medicines.

A version of this article appeared on Medscape.com.

SAN DIEGO — A liquid biopsy assay that combines a microRNA signature and a well-known biomarker for pancreatic cancer has demonstrated an accuracy of 97% for detecting stage I/II pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer.

It is quite encouraging to know we have a blood test that could potentially find this disease early, said Ajay Goel, PhD, a molecular diagnostics specialist at City of Hope in Duarte, California, who presented the findings at the annual meeting of the American Association for Cancer Research (AACR).

Dr. Goel and colleagues developed a signature for pancreatic cancer based on microRNAs identified in the exomes shed from pancreatic cancers and cell-free DNA markers found in the blood of patients with the disease.

Their initial assay tested blood samples for this signature in a training cohort of 252 people in Japan, approximately 60% of whom had pancreatic cancer. The rest were healthy controls. The assay was then tested in validation cohorts of 400 subjects, half with pancreatic cancer and half controls, in China and South Korea.

In both the initial and validation tests, the microRNA assay had an accuracy of about 90% for stage I/II pancreatic cancer, already far better than commercially available assays.

In an additional validation cohort in the United States with 139 patients with pancreatic cancer and 193 controls at six centers across the country, the researchers found that adding carbohydrate antigen 19-9 — a well-known marker of pancreatic cancer — to the assay boosted the test’s accuracy to 97%.

The test performed the same whether the tumor was in the head or tail of the pancreas.

“We are very excited about this data,” said Dr. Goel.

The technology was recently licensed to Pharus Diagnostics for commercial development, which will likely include a prospective screening trial, he told this news organization.

Because pancreatic cancer is fairly uncommon, Dr. Goel did not anticipate the test being used for general screening but rather for screening high-risk patients such as those with newly diagnosed type 2 diabetes, a family history of pancreatic cancer, or predisposing genetic mutations.

“It should be a very inexpensive test; it doesn’t cost us much to do in the lab,” he added.

Study moderator Ryan Corcoran, MD, PhD, a gastrointestinal (GI) oncologist at Massachusetts General Hospital, Boston, saw the potential.

“As a GI oncologist, I know how lethal and hard to treat pancreatic cancer is,” he said. A test that could reliably detect pancreatic cancer early, with an acceptable false-positive rate, would be extremely useful.

“The cure rate is many, many times higher,” if we detect it before it has a chance to spread, he explained.

In the meantime, Dr. Goel said there’s more work to be done.

Almost 4,000 subjects have been enrolled in ongoing validation efforts, and efforts are underway to use the test to screen thousands of banked blood samples from the PLCO, a prospective cancer screening trial in healthy subjects.

The researchers also want to see if the test can distinguish benign pancreatic cysts from ones that turn cancerous.

The idea is to find the earliest possible signs of this disease to see if we can find it not “at the moment of clinical diagnosis, but possibly 6 months, 1 year, 2 years earlier” than with radiologic imaging, Dr. Goel said.

The work was funded by the National Cancer Institute and others. Dr. Goel is a consultant for Pharus Diagnostics and Cellomics. Dr. Corcoran is a consultant for, has grants from, and/or holds stock in numerous companies, including Pfizer, Novartis, Eli Lilly, and Revolution Medicines.

A version of this article appeared on Medscape.com.

SAN DIEGO — A liquid biopsy assay that combines a microRNA signature and a well-known biomarker for pancreatic cancer has demonstrated an accuracy of 97% for detecting stage I/II pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer.

It is quite encouraging to know we have a blood test that could potentially find this disease early, said Ajay Goel, PhD, a molecular diagnostics specialist at City of Hope in Duarte, California, who presented the findings at the annual meeting of the American Association for Cancer Research (AACR).

Dr. Goel and colleagues developed a signature for pancreatic cancer based on microRNAs identified in the exomes shed from pancreatic cancers and cell-free DNA markers found in the blood of patients with the disease.

Their initial assay tested blood samples for this signature in a training cohort of 252 people in Japan, approximately 60% of whom had pancreatic cancer. The rest were healthy controls. The assay was then tested in validation cohorts of 400 subjects, half with pancreatic cancer and half controls, in China and South Korea.

In both the initial and validation tests, the microRNA assay had an accuracy of about 90% for stage I/II pancreatic cancer, already far better than commercially available assays.

In an additional validation cohort in the United States with 139 patients with pancreatic cancer and 193 controls at six centers across the country, the researchers found that adding carbohydrate antigen 19-9 — a well-known marker of pancreatic cancer — to the assay boosted the test’s accuracy to 97%.

The test performed the same whether the tumor was in the head or tail of the pancreas.

“We are very excited about this data,” said Dr. Goel.

The technology was recently licensed to Pharus Diagnostics for commercial development, which will likely include a prospective screening trial, he told this news organization.

Because pancreatic cancer is fairly uncommon, Dr. Goel did not anticipate the test being used for general screening but rather for screening high-risk patients such as those with newly diagnosed type 2 diabetes, a family history of pancreatic cancer, or predisposing genetic mutations.

“It should be a very inexpensive test; it doesn’t cost us much to do in the lab,” he added.

Study moderator Ryan Corcoran, MD, PhD, a gastrointestinal (GI) oncologist at Massachusetts General Hospital, Boston, saw the potential.

“As a GI oncologist, I know how lethal and hard to treat pancreatic cancer is,” he said. A test that could reliably detect pancreatic cancer early, with an acceptable false-positive rate, would be extremely useful.

“The cure rate is many, many times higher,” if we detect it before it has a chance to spread, he explained.

In the meantime, Dr. Goel said there’s more work to be done.

Almost 4,000 subjects have been enrolled in ongoing validation efforts, and efforts are underway to use the test to screen thousands of banked blood samples from the PLCO, a prospective cancer screening trial in healthy subjects.

The researchers also want to see if the test can distinguish benign pancreatic cysts from ones that turn cancerous.

The idea is to find the earliest possible signs of this disease to see if we can find it not “at the moment of clinical diagnosis, but possibly 6 months, 1 year, 2 years earlier” than with radiologic imaging, Dr. Goel said.

The work was funded by the National Cancer Institute and others. Dr. Goel is a consultant for Pharus Diagnostics and Cellomics. Dr. Corcoran is a consultant for, has grants from, and/or holds stock in numerous companies, including Pfizer, Novartis, Eli Lilly, and Revolution Medicines.

A version of this article appeared on Medscape.com.

Tumor necrosis factor–related apoptosis-inducing ligand (TRAIL)–targeting therapies still hold promise for treating cholangiocarcinoma (CCA) despite disappointing results in previous preclinical research, primarily due to the adaptive resistance and unexpected immune modulation, according to investigators.

Those prior studies evaluated a combination of immunotherapy and TRAIL agonism, but selective TRAIL antagonism shows greater potential via dual ligand/receptor (TRAIL/TRAIL-R) targeting to block immunosuppression, reported lead author Emilien J. Loeuillard, PhD, of Mayo Clinic, Rochester, Minnesota, and colleagues.

Loeuillard_Emilien_MN_web.jpg

“The TRAIL/TRAIL-R system has garnered considerable interest in cancer biology, especially as a potential anticancer therapy,” the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology. “However, TRAIL-R agonists have had very limited anticancer activity in human beings, challenging this concept of TRAIL as an anticancer agent.”

This may be because they were working in the wrong direction, Dr. Loeuillard and colleagues suggested, citing recent work linking TRAIL with tumor proliferation and invasion, possibly via modification of the tumor immune microenvironment.

Exact mechanisms of modification, however, remain unclear. While TRAIL has been associated with tumor-promoting effects like induction of a promyeloid secretome in adenocarcinoma, it has also been linked with anticancer effects like activation of natural killer cells and cytotoxic T lymphocytes.

“Thus, the potency and hierarchy of TRAIL anticancer vs procancer processes in cancer biology has yet to be defined,” the investigators wrote.

While TRAIL ligation of cognate receptors has been previously investigated and shown to trigger proapoptotic signaling pathways, noncanonical TRAIL-mediated signaling remains largely unexplored, particularly in CCA.

The present study evaluated TRAIL biology in CCA using immunocompetent mouse models.

These experiments showed that noncanonical TRAIL signaling immunosuppresses the tumor microenvironment by increasing quantity and activity of myeloid-derived suppressor cells (MDSCs). Blocking noncanonical TRAIL signaling by selective deletion of TRAIL-R in immune cells had significantly reduced tumor volumes alongside fewer MDSCs, driven by FLICE inhibitory protein (cFLIP)-dependent nuclear factor kappa-B activation (NF-kappa-B) in MDSCs, which has antiapoptotic activity. While MDSCs present one possible target in this chain of immunosuppression, “therapeutic strategies for targeting MDSCs are limited,” the investigators wrote, noting that available myeloid modulators have fallen short in clinical trials.

Instead, cFLIP may be a convincing option, they suggested, as targeting cFLIP can sensitize cancer cells to proapoptotic TRAIL signaling. What’s more, cFLIP appears to protect MDSCs from TRAIL-mediated apoptosis, so taking out this barrier could render MDSCs susceptible to therapy.

“Our studies suggest that switching prosurvival/proliferation TRAIL signaling to canonical proapoptotic TRAIL signaling will promote MDSC apoptosis, which in turn has therapeutic implications for CCA suppression,” the investigators wrote.

Hope therefore remains for targeting TRAIL in patients with CCA, but with selective antagonism instead of agonism, as previously attempted.

“In summary, our findings support the role of selective therapeutic targeting of TRAIL-positive cancer cells in an effort to block TRAIL/TRAIL-R–mediated tumor immunosuppression,” Dr. Loeuillard and colleagues concluded.

This study was funded by the Cholangiocarcinoma Foundation and the Mayo Clinic Eagles 5th District Cancer Telethon Funds for Research Fellowship Program, the CTSA/National Center for Advancing Translational Science, the National Institutes of Health/National Cancer Institute, and others. The investigators disclosed no conflicts of interest.

Tumor necrosis factor–related apoptosis-inducing ligand (TRAIL)–targeting therapies still hold promise for treating cholangiocarcinoma (CCA) despite disappointing results in previous preclinical research, primarily due to the adaptive resistance and unexpected immune modulation, according to investigators.

Those prior studies evaluated a combination of immunotherapy and TRAIL agonism, but selective TRAIL antagonism shows greater potential via dual ligand/receptor (TRAIL/TRAIL-R) targeting to block immunosuppression, reported lead author Emilien J. Loeuillard, PhD, of Mayo Clinic, Rochester, Minnesota, and colleagues.

Loeuillard_Emilien_MN_web.jpg

“The TRAIL/TRAIL-R system has garnered considerable interest in cancer biology, especially as a potential anticancer therapy,” the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology. “However, TRAIL-R agonists have had very limited anticancer activity in human beings, challenging this concept of TRAIL as an anticancer agent.”

This may be because they were working in the wrong direction, Dr. Loeuillard and colleagues suggested, citing recent work linking TRAIL with tumor proliferation and invasion, possibly via modification of the tumor immune microenvironment.

Exact mechanisms of modification, however, remain unclear. While TRAIL has been associated with tumor-promoting effects like induction of a promyeloid secretome in adenocarcinoma, it has also been linked with anticancer effects like activation of natural killer cells and cytotoxic T lymphocytes.

“Thus, the potency and hierarchy of TRAIL anticancer vs procancer processes in cancer biology has yet to be defined,” the investigators wrote.

While TRAIL ligation of cognate receptors has been previously investigated and shown to trigger proapoptotic signaling pathways, noncanonical TRAIL-mediated signaling remains largely unexplored, particularly in CCA.

The present study evaluated TRAIL biology in CCA using immunocompetent mouse models.

These experiments showed that noncanonical TRAIL signaling immunosuppresses the tumor microenvironment by increasing quantity and activity of myeloid-derived suppressor cells (MDSCs). Blocking noncanonical TRAIL signaling by selective deletion of TRAIL-R in immune cells had significantly reduced tumor volumes alongside fewer MDSCs, driven by FLICE inhibitory protein (cFLIP)-dependent nuclear factor kappa-B activation (NF-kappa-B) in MDSCs, which has antiapoptotic activity. While MDSCs present one possible target in this chain of immunosuppression, “therapeutic strategies for targeting MDSCs are limited,” the investigators wrote, noting that available myeloid modulators have fallen short in clinical trials.

Instead, cFLIP may be a convincing option, they suggested, as targeting cFLIP can sensitize cancer cells to proapoptotic TRAIL signaling. What’s more, cFLIP appears to protect MDSCs from TRAIL-mediated apoptosis, so taking out this barrier could render MDSCs susceptible to therapy.

“Our studies suggest that switching prosurvival/proliferation TRAIL signaling to canonical proapoptotic TRAIL signaling will promote MDSC apoptosis, which in turn has therapeutic implications for CCA suppression,” the investigators wrote.

Hope therefore remains for targeting TRAIL in patients with CCA, but with selective antagonism instead of agonism, as previously attempted.

“In summary, our findings support the role of selective therapeutic targeting of TRAIL-positive cancer cells in an effort to block TRAIL/TRAIL-R–mediated tumor immunosuppression,” Dr. Loeuillard and colleagues concluded.

This study was funded by the Cholangiocarcinoma Foundation and the Mayo Clinic Eagles 5th District Cancer Telethon Funds for Research Fellowship Program, the CTSA/National Center for Advancing Translational Science, the National Institutes of Health/National Cancer Institute, and others. The investigators disclosed no conflicts of interest.

Tumor necrosis factor–related apoptosis-inducing ligand (TRAIL)–targeting therapies still hold promise for treating cholangiocarcinoma (CCA) despite disappointing results in previous preclinical research, primarily due to the adaptive resistance and unexpected immune modulation, according to investigators.

Those prior studies evaluated a combination of immunotherapy and TRAIL agonism, but selective TRAIL antagonism shows greater potential via dual ligand/receptor (TRAIL/TRAIL-R) targeting to block immunosuppression, reported lead author Emilien J. Loeuillard, PhD, of Mayo Clinic, Rochester, Minnesota, and colleagues.

Loeuillard_Emilien_MN_web.jpg

“The TRAIL/TRAIL-R system has garnered considerable interest in cancer biology, especially as a potential anticancer therapy,” the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology. “However, TRAIL-R agonists have had very limited anticancer activity in human beings, challenging this concept of TRAIL as an anticancer agent.”

This may be because they were working in the wrong direction, Dr. Loeuillard and colleagues suggested, citing recent work linking TRAIL with tumor proliferation and invasion, possibly via modification of the tumor immune microenvironment.

Exact mechanisms of modification, however, remain unclear. While TRAIL has been associated with tumor-promoting effects like induction of a promyeloid secretome in adenocarcinoma, it has also been linked with anticancer effects like activation of natural killer cells and cytotoxic T lymphocytes.

“Thus, the potency and hierarchy of TRAIL anticancer vs procancer processes in cancer biology has yet to be defined,” the investigators wrote.

While TRAIL ligation of cognate receptors has been previously investigated and shown to trigger proapoptotic signaling pathways, noncanonical TRAIL-mediated signaling remains largely unexplored, particularly in CCA.

The present study evaluated TRAIL biology in CCA using immunocompetent mouse models.

These experiments showed that noncanonical TRAIL signaling immunosuppresses the tumor microenvironment by increasing quantity and activity of myeloid-derived suppressor cells (MDSCs). Blocking noncanonical TRAIL signaling by selective deletion of TRAIL-R in immune cells had significantly reduced tumor volumes alongside fewer MDSCs, driven by FLICE inhibitory protein (cFLIP)-dependent nuclear factor kappa-B activation (NF-kappa-B) in MDSCs, which has antiapoptotic activity. While MDSCs present one possible target in this chain of immunosuppression, “therapeutic strategies for targeting MDSCs are limited,” the investigators wrote, noting that available myeloid modulators have fallen short in clinical trials.

Instead, cFLIP may be a convincing option, they suggested, as targeting cFLIP can sensitize cancer cells to proapoptotic TRAIL signaling. What’s more, cFLIP appears to protect MDSCs from TRAIL-mediated apoptosis, so taking out this barrier could render MDSCs susceptible to therapy.

“Our studies suggest that switching prosurvival/proliferation TRAIL signaling to canonical proapoptotic TRAIL signaling will promote MDSC apoptosis, which in turn has therapeutic implications for CCA suppression,” the investigators wrote.

Hope therefore remains for targeting TRAIL in patients with CCA, but with selective antagonism instead of agonism, as previously attempted.

“In summary, our findings support the role of selective therapeutic targeting of TRAIL-positive cancer cells in an effort to block TRAIL/TRAIL-R–mediated tumor immunosuppression,” Dr. Loeuillard and colleagues concluded.

This study was funded by the Cholangiocarcinoma Foundation and the Mayo Clinic Eagles 5th District Cancer Telethon Funds for Research Fellowship Program, the CTSA/National Center for Advancing Translational Science, the National Institutes of Health/National Cancer Institute, and others. The investigators disclosed no conflicts of interest.

Power-washing is no longer just for blasting grimy driveways and stripping flaky paint. It’s good for work inside the gut, too.

In a proof-of-concept study, a “novel systematically directed high-pressure liquid spray,” delivered via the ERBEJET flexible probe, showed promise for collecting cytology specimens from the stomachs of patients undergoing endoscopy for gastric cancer screening or surveillance, reported lead author Charles J. Lightdale, MD, of Columbia University Irving Medical Center, New York City, and colleagues.

“Systematic random biopsies (updated Sydney protocol) have been recommended to increase detection of gastric intestinal metaplasia (GIM) and dysplasia,” the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy. “However, random biopsies can be laborious, time consuming, costly, and susceptible to sampling error owing to the large surface area of the stomach.”

Power-washing, in contrast, with the pressure dial turned to 10 bar, involves spraying the gut in a systematic fashion “using sweeping and painting motions” to dislodge cells from the mucosa. These specimens are then suctioned from the resultant pools of liquid, mixed 1:1 with 10% formalin, and shipped to the lab.
 

Boom! Cytology!

Just to be sure, however, the nine patients involved in the study also underwent standard-of-care biopsy collection from areas of interest, followed by random sampling according to the updated Sydney protocol. Two of the patients were power-washed again 12 months later for endoscopic surveillance.

Power-washing added 7-10 minutes to standard endoscopy time and generated 60-100 mL of liquid for collection. Post suction, a closer look at the gastric mucosa revealed “scattered superficial erosions,” while blood loss was deemed “minimal.” The procedure appeared well tolerated, with no aspiration or esophageal reflux during endoscopy, or adverse events reported by patients after 1 week of follow-up.

Cytopathology samples were deemed satisfactory and yielded “multiple strips and large clusters of cells.” These were sufficient to diagnose GIM in three patients and reactive glandular changes with inflammation in one patient, with findings confirmed on biopsy. In contrast, the power-washed cells from one patient were “highly suspicious” for dysplasia, but biopsies were negative.

Although the study was too small for a reliable comparison with the Sydney protocol, Dr. Lightdale and colleagues concluded that the power-wash approach deserves further investigation.

“Use of power-wash to obtain cytology has the potential to improve endoscopic screening and surveillance protocols for detecting GIM and dysplasia and to reduce morbidity and mortality from gastric cancer,” they wrote.

The investigators predicted that power-washing is likely safe in most patients, although it may be unsuitable for those with noncorrectable coagulopathies or in patients who cannot stop anticoagulants. Postsurgical patients, on the other hand, should tolerate the procedure just fine.

Patients with risk of gastric cancer “might be an important group” for evaluating the power-wash procedure, the investigators wrote, noting that combining the approach with artificial intelligence could one day yield even better results.

In the meantime, Dr. Lightdale and colleagues — like so many weekend warriors wielding a power-washer — are going to see if a different nozzle will take their work to the next level.

“We are actively studying a catheter with a broader stream and the potential to increase efficiency and decrease procedure time,” they wrote. “Another catheter design might allow for simultaneous spray and suction, so that cytology samples from specific regions of the stomach could be separately analyzed.”

This study was funded by Dalio Philanthropies, the Price Family Foundation, and the Frederic and Patricia Salerno Foundation. The investigators disclosed relationships with Boston Scientific, Interscope, Medtronic, and others.

Power-washing is no longer just for blasting grimy driveways and stripping flaky paint. It’s good for work inside the gut, too.

In a proof-of-concept study, a “novel systematically directed high-pressure liquid spray,” delivered via the ERBEJET flexible probe, showed promise for collecting cytology specimens from the stomachs of patients undergoing endoscopy for gastric cancer screening or surveillance, reported lead author Charles J. Lightdale, MD, of Columbia University Irving Medical Center, New York City, and colleagues.

“Systematic random biopsies (updated Sydney protocol) have been recommended to increase detection of gastric intestinal metaplasia (GIM) and dysplasia,” the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy. “However, random biopsies can be laborious, time consuming, costly, and susceptible to sampling error owing to the large surface area of the stomach.”

Power-washing, in contrast, with the pressure dial turned to 10 bar, involves spraying the gut in a systematic fashion “using sweeping and painting motions” to dislodge cells from the mucosa. These specimens are then suctioned from the resultant pools of liquid, mixed 1:1 with 10% formalin, and shipped to the lab.
 

Boom! Cytology!

Just to be sure, however, the nine patients involved in the study also underwent standard-of-care biopsy collection from areas of interest, followed by random sampling according to the updated Sydney protocol. Two of the patients were power-washed again 12 months later for endoscopic surveillance.

Power-washing added 7-10 minutes to standard endoscopy time and generated 60-100 mL of liquid for collection. Post suction, a closer look at the gastric mucosa revealed “scattered superficial erosions,” while blood loss was deemed “minimal.” The procedure appeared well tolerated, with no aspiration or esophageal reflux during endoscopy, or adverse events reported by patients after 1 week of follow-up.

Cytopathology samples were deemed satisfactory and yielded “multiple strips and large clusters of cells.” These were sufficient to diagnose GIM in three patients and reactive glandular changes with inflammation in one patient, with findings confirmed on biopsy. In contrast, the power-washed cells from one patient were “highly suspicious” for dysplasia, but biopsies were negative.

Although the study was too small for a reliable comparison with the Sydney protocol, Dr. Lightdale and colleagues concluded that the power-wash approach deserves further investigation.

“Use of power-wash to obtain cytology has the potential to improve endoscopic screening and surveillance protocols for detecting GIM and dysplasia and to reduce morbidity and mortality from gastric cancer,” they wrote.

The investigators predicted that power-washing is likely safe in most patients, although it may be unsuitable for those with noncorrectable coagulopathies or in patients who cannot stop anticoagulants. Postsurgical patients, on the other hand, should tolerate the procedure just fine.

Patients with risk of gastric cancer “might be an important group” for evaluating the power-wash procedure, the investigators wrote, noting that combining the approach with artificial intelligence could one day yield even better results.

In the meantime, Dr. Lightdale and colleagues — like so many weekend warriors wielding a power-washer — are going to see if a different nozzle will take their work to the next level.

“We are actively studying a catheter with a broader stream and the potential to increase efficiency and decrease procedure time,” they wrote. “Another catheter design might allow for simultaneous spray and suction, so that cytology samples from specific regions of the stomach could be separately analyzed.”

This study was funded by Dalio Philanthropies, the Price Family Foundation, and the Frederic and Patricia Salerno Foundation. The investigators disclosed relationships with Boston Scientific, Interscope, Medtronic, and others.

Power-washing is no longer just for blasting grimy driveways and stripping flaky paint. It’s good for work inside the gut, too.

In a proof-of-concept study, a “novel systematically directed high-pressure liquid spray,” delivered via the ERBEJET flexible probe, showed promise for collecting cytology specimens from the stomachs of patients undergoing endoscopy for gastric cancer screening or surveillance, reported lead author Charles J. Lightdale, MD, of Columbia University Irving Medical Center, New York City, and colleagues.

“Systematic random biopsies (updated Sydney protocol) have been recommended to increase detection of gastric intestinal metaplasia (GIM) and dysplasia,” the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy. “However, random biopsies can be laborious, time consuming, costly, and susceptible to sampling error owing to the large surface area of the stomach.”

Power-washing, in contrast, with the pressure dial turned to 10 bar, involves spraying the gut in a systematic fashion “using sweeping and painting motions” to dislodge cells from the mucosa. These specimens are then suctioned from the resultant pools of liquid, mixed 1:1 with 10% formalin, and shipped to the lab.
 

Boom! Cytology!

Just to be sure, however, the nine patients involved in the study also underwent standard-of-care biopsy collection from areas of interest, followed by random sampling according to the updated Sydney protocol. Two of the patients were power-washed again 12 months later for endoscopic surveillance.

Power-washing added 7-10 minutes to standard endoscopy time and generated 60-100 mL of liquid for collection. Post suction, a closer look at the gastric mucosa revealed “scattered superficial erosions,” while blood loss was deemed “minimal.” The procedure appeared well tolerated, with no aspiration or esophageal reflux during endoscopy, or adverse events reported by patients after 1 week of follow-up.

Cytopathology samples were deemed satisfactory and yielded “multiple strips and large clusters of cells.” These were sufficient to diagnose GIM in three patients and reactive glandular changes with inflammation in one patient, with findings confirmed on biopsy. In contrast, the power-washed cells from one patient were “highly suspicious” for dysplasia, but biopsies were negative.

Although the study was too small for a reliable comparison with the Sydney protocol, Dr. Lightdale and colleagues concluded that the power-wash approach deserves further investigation.

“Use of power-wash to obtain cytology has the potential to improve endoscopic screening and surveillance protocols for detecting GIM and dysplasia and to reduce morbidity and mortality from gastric cancer,” they wrote.

The investigators predicted that power-washing is likely safe in most patients, although it may be unsuitable for those with noncorrectable coagulopathies or in patients who cannot stop anticoagulants. Postsurgical patients, on the other hand, should tolerate the procedure just fine.

Patients with risk of gastric cancer “might be an important group” for evaluating the power-wash procedure, the investigators wrote, noting that combining the approach with artificial intelligence could one day yield even better results.

In the meantime, Dr. Lightdale and colleagues — like so many weekend warriors wielding a power-washer — are going to see if a different nozzle will take their work to the next level.

“We are actively studying a catheter with a broader stream and the potential to increase efficiency and decrease procedure time,” they wrote. “Another catheter design might allow for simultaneous spray and suction, so that cytology samples from specific regions of the stomach could be separately analyzed.”

This study was funded by Dalio Philanthropies, the Price Family Foundation, and the Frederic and Patricia Salerno Foundation. The investigators disclosed relationships with Boston Scientific, Interscope, Medtronic, and others.

A newly developed quality performance measure that tracks completion of colorectal cancer (CRC) screening with a colonoscopy within 6 months of an abnormal stool-based screening test (SBT) in adults could help address high rates of incomplete CRC screening, the developers said.

As part of their work, the researchers conducted a retrospective study of 20,581 adults aged 50-75 years from 38 health systems that showed that fewer than half (48%) had a follow-up colonoscopy within 180 days of an initial abnormal SBT for CRC.

“The low follow-up rates to an abnormal SBT were initially surprising,” first author Elizabeth L. Ciemins, PhD, MPH, MA, Research and Analytics, American Medical Group Association (AMGA), Alexandria, Virginia, told this news organization.

“However, once we interviewed clinicians and learned that this was not a measure they were tracking, along with their own incorrect assumptions of a much higher follow-up rate, the low rates made sense. As is commonly said, ‘you can’t change what you don’t measure,’” she said.

The CRC screening completion measure the researchers propose “builds on and addresses an important shortcoming in an existing measure and will help ensure complete screening for CRC,” they noted in their JAMA Network Open paper.

The key elements of the follow-up measure are the date and result of a SBT and the date of the follow-up colonoscopy — if it occurred, Dr. Ciemins explained.

“Currently, health systems are not consistently tracking this measure, but they have the data elements to do so, especially if they are doing colonoscopies in-house,” she said.

Field testing showed that use of this new measure is “feasible, valid, and reliable,” the authors said. Dr. Ciemins believed this CRC screening completion measure could be widely implemented.

“Three AMGA member health systems feasibility tested the data elements and found that they could reliably abstract the required elements from electronic health records (EHRs),” she told this news organization.

The researchers are currently testing the measure among 20 AMGA member health systems, that are submitting quarterly data on a version of the specified measure.

“Advancing this measure as a quality performance measure could significantly increase the early detection of CRC, thereby improving health and ultimately saving lives,” the authors concluded in their paper.

The Right Direction, But Questions Remain

The coauthors of a linked commentary said this research highlights the “suboptimal” rates of a timely follow-up colonoscopy after positive SBT results. They applauded the authors for “focusing attention on a meaningful approach to measuring high-quality CRC screening and providing guidance for standardized measurement.”

However, several questions arise from this study, “including whether 6 months is the ideal interval for colonoscopy completion after a positive SBT result, where this measure fits in the context of existing CRC screening measures, and how to implement it in practice,” Jennifer K. Maratt, MD, with Indiana University School of Medicine, Indianapolis, and coauthors wrote.

“This measure alone does not address all the gaps in the screening process, nor does it address barriers to colonoscopy completion, but it points us in the right direction for measuring the success of screening programs,” Dr. Maratt and her colleagues added.

The study was supported by a grant from the AARP. The authors and editorial writers had no relevant disclosures.

A version of this article appeared on Medscape.com.

A newly developed quality performance measure that tracks completion of colorectal cancer (CRC) screening with a colonoscopy within 6 months of an abnormal stool-based screening test (SBT) in adults could help address high rates of incomplete CRC screening, the developers said.

As part of their work, the researchers conducted a retrospective study of 20,581 adults aged 50-75 years from 38 health systems that showed that fewer than half (48%) had a follow-up colonoscopy within 180 days of an initial abnormal SBT for CRC.

“The low follow-up rates to an abnormal SBT were initially surprising,” first author Elizabeth L. Ciemins, PhD, MPH, MA, Research and Analytics, American Medical Group Association (AMGA), Alexandria, Virginia, told this news organization.

“However, once we interviewed clinicians and learned that this was not a measure they were tracking, along with their own incorrect assumptions of a much higher follow-up rate, the low rates made sense. As is commonly said, ‘you can’t change what you don’t measure,’” she said.

The CRC screening completion measure the researchers propose “builds on and addresses an important shortcoming in an existing measure and will help ensure complete screening for CRC,” they noted in their JAMA Network Open paper.

The key elements of the follow-up measure are the date and result of a SBT and the date of the follow-up colonoscopy — if it occurred, Dr. Ciemins explained.

“Currently, health systems are not consistently tracking this measure, but they have the data elements to do so, especially if they are doing colonoscopies in-house,” she said.

Field testing showed that use of this new measure is “feasible, valid, and reliable,” the authors said. Dr. Ciemins believed this CRC screening completion measure could be widely implemented.

“Three AMGA member health systems feasibility tested the data elements and found that they could reliably abstract the required elements from electronic health records (EHRs),” she told this news organization.

The researchers are currently testing the measure among 20 AMGA member health systems, that are submitting quarterly data on a version of the specified measure.

“Advancing this measure as a quality performance measure could significantly increase the early detection of CRC, thereby improving health and ultimately saving lives,” the authors concluded in their paper.

The Right Direction, But Questions Remain

The coauthors of a linked commentary said this research highlights the “suboptimal” rates of a timely follow-up colonoscopy after positive SBT results. They applauded the authors for “focusing attention on a meaningful approach to measuring high-quality CRC screening and providing guidance for standardized measurement.”

However, several questions arise from this study, “including whether 6 months is the ideal interval for colonoscopy completion after a positive SBT result, where this measure fits in the context of existing CRC screening measures, and how to implement it in practice,” Jennifer K. Maratt, MD, with Indiana University School of Medicine, Indianapolis, and coauthors wrote.

“This measure alone does not address all the gaps in the screening process, nor does it address barriers to colonoscopy completion, but it points us in the right direction for measuring the success of screening programs,” Dr. Maratt and her colleagues added.

The study was supported by a grant from the AARP. The authors and editorial writers had no relevant disclosures.

A version of this article appeared on Medscape.com.

A newly developed quality performance measure that tracks completion of colorectal cancer (CRC) screening with a colonoscopy within 6 months of an abnormal stool-based screening test (SBT) in adults could help address high rates of incomplete CRC screening, the developers said.

As part of their work, the researchers conducted a retrospective study of 20,581 adults aged 50-75 years from 38 health systems that showed that fewer than half (48%) had a follow-up colonoscopy within 180 days of an initial abnormal SBT for CRC.

“The low follow-up rates to an abnormal SBT were initially surprising,” first author Elizabeth L. Ciemins, PhD, MPH, MA, Research and Analytics, American Medical Group Association (AMGA), Alexandria, Virginia, told this news organization.

“However, once we interviewed clinicians and learned that this was not a measure they were tracking, along with their own incorrect assumptions of a much higher follow-up rate, the low rates made sense. As is commonly said, ‘you can’t change what you don’t measure,’” she said.

The CRC screening completion measure the researchers propose “builds on and addresses an important shortcoming in an existing measure and will help ensure complete screening for CRC,” they noted in their JAMA Network Open paper.

The key elements of the follow-up measure are the date and result of a SBT and the date of the follow-up colonoscopy — if it occurred, Dr. Ciemins explained.

“Currently, health systems are not consistently tracking this measure, but they have the data elements to do so, especially if they are doing colonoscopies in-house,” she said.

Field testing showed that use of this new measure is “feasible, valid, and reliable,” the authors said. Dr. Ciemins believed this CRC screening completion measure could be widely implemented.

“Three AMGA member health systems feasibility tested the data elements and found that they could reliably abstract the required elements from electronic health records (EHRs),” she told this news organization.

The researchers are currently testing the measure among 20 AMGA member health systems, that are submitting quarterly data on a version of the specified measure.

“Advancing this measure as a quality performance measure could significantly increase the early detection of CRC, thereby improving health and ultimately saving lives,” the authors concluded in their paper.

The Right Direction, But Questions Remain

The coauthors of a linked commentary said this research highlights the “suboptimal” rates of a timely follow-up colonoscopy after positive SBT results. They applauded the authors for “focusing attention on a meaningful approach to measuring high-quality CRC screening and providing guidance for standardized measurement.”

However, several questions arise from this study, “including whether 6 months is the ideal interval for colonoscopy completion after a positive SBT result, where this measure fits in the context of existing CRC screening measures, and how to implement it in practice,” Jennifer K. Maratt, MD, with Indiana University School of Medicine, Indianapolis, and coauthors wrote.

“This measure alone does not address all the gaps in the screening process, nor does it address barriers to colonoscopy completion, but it points us in the right direction for measuring the success of screening programs,” Dr. Maratt and her colleagues added.

The study was supported by a grant from the AARP. The authors and editorial writers had no relevant disclosures.

A version of this article appeared on Medscape.com.

Colonoscopy with computer-aided detection (CADe) fails to improve adenoma detection rate (ADR) in real-world, nonrandomized trials, according to investigators.

Although CADe did not increase burden of colonoscopy in the real-world, these real-world detection rates casts doubt on the generalizability of positive findings from randomized trials, reported lead author Harsh K. Patel, MD, of the University of Kansas Medical Center, Kansas City, Missouri, and colleagues.

CADe-assisted colonoscopy has gained increasing attention for its potential to improve ADR, particularly with the recent publication of a meta-analysis involving 20 randomized controlled trials (RCTs), Dr. Patel and colleagues wrote in Clinical Gastroenterology and Hepatology. “However, results of RCTs are not necessarily reproducible in clinical practice.”

RCTs evaluating this technology are susceptible to various issues with validity, they noted, such as psychological bias stemming from lack of blinding to the possibility that CADe could reduce operator attention, paradoxically “deskilling” endoscopists.

The present meta-analysis aimed to overcome these potential shortfalls by analyzing nonrandomized data from eight studies involving 9,782 patients.

Patel_Harsh_K_MO_web.jpg

“The lack of a highly controlled setting reduces the psychological pressure of the endoscopists to demonstrate a possible benefit of CADe (i.e., the operator bias) and allows endoscopists to use CADe according to their preferences and attitudes which we usually experience in a real-world clinical practice,” the investigators wrote. “On the other hand, noncontrolled factors may affect the outcome of the study, especially when considering that an equivalent distribution of prevalence of disease is required for a fair assessment of the effectiveness of the intervention.”

This approach revealed less favorable outcomes than those reported by RCTs.

CADe-assisted ADR was not significantly different from ADR for standard colonoscopy (44% vs 38%; risk ratio, 1.11; 95% CI, 0.97-1.28), nor was mean number of adenomas detected per colonoscopy (0.93 vs 0.79; mean difference, 0.14; 95% CI, -0.04-0.32).

“Our study provides a contrasting perspective to those results previously known from the randomized studies,” the investigators wrote.

While detection benefits were not identified, burden of CADe-assisted colonoscopy was not elevated either.

Mean nonneoplastic lesions per colonoscopy was similar between modalities (0.52 vs 0.47; mean difference, 0.14; 95% CI, -0.07-0.34), as was withdrawal time (14.3 vs 13.4 minutes; mean difference, 0.8 minutes; 95% CI, -0.18-1.90).

Dr. Patel and colleagues described “a high level of heterogeneity that was qualitatively and quantitatively distinct from the heterogeneity discovered in the prior meta-analysis of RCTs.” Unlike the RCT meta-analysis, which had no studies with an ADR outcome favoring the control arm, the present meta-analysis found that one third of the included studies favored the control arm.

“This qualitative difference generates a much higher degree of ambiguity, as it does not apply only to the magnitude of the effect of CADe, but it puts in question the actual existence of any CADe-related benefit,” they wrote. “An important point to make is that the analysis of adenoma and serrated lesions per colonoscopy supported the qualitative heterogeneity, favoring the control arm over the CADe arm, in the direction of the effect.”

Dr. Patel and colleagues suggested that the concurrent lack of benefit and lack of harm associated with CADe in the present meta-analysis is “interesting,” and may point to underutilization or a lack of effect of CADe.

“To address the uncertainties in the current literature, we recommend conducting additional randomized studies in a more pragmatic setting,” they concluded.

This meta-analysis was supported by the European Commission and AIRC. The investigators disclosed relationships with NEC, Satisfy, Odin, and others.

Colonoscopy with computer-aided detection (CADe) fails to improve adenoma detection rate (ADR) in real-world, nonrandomized trials, according to investigators.

Although CADe did not increase burden of colonoscopy in the real-world, these real-world detection rates casts doubt on the generalizability of positive findings from randomized trials, reported lead author Harsh K. Patel, MD, of the University of Kansas Medical Center, Kansas City, Missouri, and colleagues.

CADe-assisted colonoscopy has gained increasing attention for its potential to improve ADR, particularly with the recent publication of a meta-analysis involving 20 randomized controlled trials (RCTs), Dr. Patel and colleagues wrote in Clinical Gastroenterology and Hepatology. “However, results of RCTs are not necessarily reproducible in clinical practice.”

RCTs evaluating this technology are susceptible to various issues with validity, they noted, such as psychological bias stemming from lack of blinding to the possibility that CADe could reduce operator attention, paradoxically “deskilling” endoscopists.

The present meta-analysis aimed to overcome these potential shortfalls by analyzing nonrandomized data from eight studies involving 9,782 patients.

Patel_Harsh_K_MO_web.jpg

“The lack of a highly controlled setting reduces the psychological pressure of the endoscopists to demonstrate a possible benefit of CADe (i.e., the operator bias) and allows endoscopists to use CADe according to their preferences and attitudes which we usually experience in a real-world clinical practice,” the investigators wrote. “On the other hand, noncontrolled factors may affect the outcome of the study, especially when considering that an equivalent distribution of prevalence of disease is required for a fair assessment of the effectiveness of the intervention.”

This approach revealed less favorable outcomes than those reported by RCTs.

CADe-assisted ADR was not significantly different from ADR for standard colonoscopy (44% vs 38%; risk ratio, 1.11; 95% CI, 0.97-1.28), nor was mean number of adenomas detected per colonoscopy (0.93 vs 0.79; mean difference, 0.14; 95% CI, -0.04-0.32).

“Our study provides a contrasting perspective to those results previously known from the randomized studies,” the investigators wrote.

While detection benefits were not identified, burden of CADe-assisted colonoscopy was not elevated either.

Mean nonneoplastic lesions per colonoscopy was similar between modalities (0.52 vs 0.47; mean difference, 0.14; 95% CI, -0.07-0.34), as was withdrawal time (14.3 vs 13.4 minutes; mean difference, 0.8 minutes; 95% CI, -0.18-1.90).

Dr. Patel and colleagues described “a high level of heterogeneity that was qualitatively and quantitatively distinct from the heterogeneity discovered in the prior meta-analysis of RCTs.” Unlike the RCT meta-analysis, which had no studies with an ADR outcome favoring the control arm, the present meta-analysis found that one third of the included studies favored the control arm.

“This qualitative difference generates a much higher degree of ambiguity, as it does not apply only to the magnitude of the effect of CADe, but it puts in question the actual existence of any CADe-related benefit,” they wrote. “An important point to make is that the analysis of adenoma and serrated lesions per colonoscopy supported the qualitative heterogeneity, favoring the control arm over the CADe arm, in the direction of the effect.”

Dr. Patel and colleagues suggested that the concurrent lack of benefit and lack of harm associated with CADe in the present meta-analysis is “interesting,” and may point to underutilization or a lack of effect of CADe.

“To address the uncertainties in the current literature, we recommend conducting additional randomized studies in a more pragmatic setting,” they concluded.

This meta-analysis was supported by the European Commission and AIRC. The investigators disclosed relationships with NEC, Satisfy, Odin, and others.

Colonoscopy with computer-aided detection (CADe) fails to improve adenoma detection rate (ADR) in real-world, nonrandomized trials, according to investigators.

Although CADe did not increase burden of colonoscopy in the real-world, these real-world detection rates casts doubt on the generalizability of positive findings from randomized trials, reported lead author Harsh K. Patel, MD, of the University of Kansas Medical Center, Kansas City, Missouri, and colleagues.

CADe-assisted colonoscopy has gained increasing attention for its potential to improve ADR, particularly with the recent publication of a meta-analysis involving 20 randomized controlled trials (RCTs), Dr. Patel and colleagues wrote in Clinical Gastroenterology and Hepatology. “However, results of RCTs are not necessarily reproducible in clinical practice.”

RCTs evaluating this technology are susceptible to various issues with validity, they noted, such as psychological bias stemming from lack of blinding to the possibility that CADe could reduce operator attention, paradoxically “deskilling” endoscopists.

The present meta-analysis aimed to overcome these potential shortfalls by analyzing nonrandomized data from eight studies involving 9,782 patients.

Patel_Harsh_K_MO_web.jpg

“The lack of a highly controlled setting reduces the psychological pressure of the endoscopists to demonstrate a possible benefit of CADe (i.e., the operator bias) and allows endoscopists to use CADe according to their preferences and attitudes which we usually experience in a real-world clinical practice,” the investigators wrote. “On the other hand, noncontrolled factors may affect the outcome of the study, especially when considering that an equivalent distribution of prevalence of disease is required for a fair assessment of the effectiveness of the intervention.”

This approach revealed less favorable outcomes than those reported by RCTs.

CADe-assisted ADR was not significantly different from ADR for standard colonoscopy (44% vs 38%; risk ratio, 1.11; 95% CI, 0.97-1.28), nor was mean number of adenomas detected per colonoscopy (0.93 vs 0.79; mean difference, 0.14; 95% CI, -0.04-0.32).

“Our study provides a contrasting perspective to those results previously known from the randomized studies,” the investigators wrote.

While detection benefits were not identified, burden of CADe-assisted colonoscopy was not elevated either.

Mean nonneoplastic lesions per colonoscopy was similar between modalities (0.52 vs 0.47; mean difference, 0.14; 95% CI, -0.07-0.34), as was withdrawal time (14.3 vs 13.4 minutes; mean difference, 0.8 minutes; 95% CI, -0.18-1.90).

Dr. Patel and colleagues described “a high level of heterogeneity that was qualitatively and quantitatively distinct from the heterogeneity discovered in the prior meta-analysis of RCTs.” Unlike the RCT meta-analysis, which had no studies with an ADR outcome favoring the control arm, the present meta-analysis found that one third of the included studies favored the control arm.

“This qualitative difference generates a much higher degree of ambiguity, as it does not apply only to the magnitude of the effect of CADe, but it puts in question the actual existence of any CADe-related benefit,” they wrote. “An important point to make is that the analysis of adenoma and serrated lesions per colonoscopy supported the qualitative heterogeneity, favoring the control arm over the CADe arm, in the direction of the effect.”

Dr. Patel and colleagues suggested that the concurrent lack of benefit and lack of harm associated with CADe in the present meta-analysis is “interesting,” and may point to underutilization or a lack of effect of CADe.

“To address the uncertainties in the current literature, we recommend conducting additional randomized studies in a more pragmatic setting,” they concluded.

This meta-analysis was supported by the European Commission and AIRC. The investigators disclosed relationships with NEC, Satisfy, Odin, and others.

Growing up in a household where GI issues dominated conversations, it’s no surprise that Shida Haghighat, MD, chose gastroenterology as her area of study in medicine.

She watched her father suffer from the complications of Crohn’s disease and her brother struggle with irritable bowel syndrome. “We always needed to know where the nearest bathroom was. I grew up with that around me, and I was always just fascinated by the gut and the digestive system,” said Dr. Haghighat, who just finished up her fellowship at the University of Miami and is now a gastroenterologist at University of California, Los Angeles. She also serves as social media editor for AGA’s Gastro Hep Advances.

Haghighat_Shida_CA_web.jpg

As she got to know the personalities of the GI department in the first year of medical school, “I realized that our senses of humor and personalities kind of aligned, and I was like, ‘Oh yeah, this is where I’m supposed to be,’ ” said Dr. Haghighat, who can be found on X @DoctorShida.

Humor is something Dr. Haghighat has reached for throughout her life and career. She eventually channeled her gift for satire onto the stage and the internet, as a stand-up comedian. In an interview with GI & Hepatology News, she spoke about the connection between GI medicine and humor, and the creative ways she has helped promote cancer screening in underserved populations.
 

Q: What practice challenges have you faced in your career?

Dr. Haghighat: I trained in a county hospital, so I’ve always worked with underserved and vulnerable populations. One of the challenges has been just navigation of care, especially as it pertains to cancer diagnoses or cancer screening. A lot of the time, patients don’t understand why they have to do a test or something invasive like a colonoscopy for symptoms they don’t have. 

Q: A focus of yours has been improving uptake of screening in underserved communities. Please talk about the work you’ve done in this area.

Dr. Haghighat: I was at Los Angeles General Medical Center — a county hospital in Los Angeles — for residency, where we treated underserved, uninsured patients. I noticed in our primary care clinics a very low uptake of colon cancer screening. Patients didn’t want to bring the stool tests back or get colonoscopies. I surveyed a bunch of the patients and asked: How can we make colon cancer screening easier for you? About a third of the patients said, “If I can do it in the clinic before I go home, that would be great.”

So, I started this initiative called “Go Before You Go.” We would ask patients, “Hey, do you need to go to the bathroom right now, if you can?” Our nurses handed them the stool test to do in the bathroom before they left the clinic after their doctor visits.

We saw really good results with that. Surprisingly, a lot of people can go on demand. We saw increased screening rates, and that quality improvement project went on to win multiple first place awards in research competitions. So that’s what got me interested, and that’s where I had my beginnings of increasing preventative services in underserved communities on the ground.
 

Q: Can you discuss some health disparity studies you’ve done in this area?

Dr. Haghighat: As a GI at Jackson Memorial Hospital in Miami, I was seeing cancer disparities firsthand every day. I wanted to approach these disparities from a research funding standpoint on a federal level. I was particularly interested in gastric cancer because it’s not common enough in the United States to warrant universal screening, but it’s very common among certain racial and ethnic minorities, which would warrant targeted screening.

I evaluated cancer funding allocation from the National Cancer Institute among the most common cancers in the United States and found that cancer afflicting a higher proportion of racial and ethnic minorities was receiving lower funding. One of those cancers was stomach cancer. This study basically highlighted that, to decrease these disparities, a top-down policy approach is necessary to distribute cancer research funding equitably across these groups. 

A lot of stomach cancer comes from a bacteria called Helicobacter pylori, which can be more prevalent in certain countries. In another study, I looked at country of birth as a risk factor for stomach cancer, specifically for gastric intestinal metaplasia, which is a precursor for gastric cancer . 

We found that country of birth is a key risk factor for gastric intestinal metaplasia and that it should be incorporated into risk stratification for targeted screening. 
 

Q: Outside of medicine, you perform as a stand-up comedian. You have a popular satirical alias on social media. How did you get interested in stand-up comedy?

Dr. Haghighat: I gave my medical school’s commencement speech, and I had sprinkled a few jokes in there. Afterward, multiple people approached me and said, “You should really consider stand-up comedy. Your timing and delivery are great.” A few months later, I started my intern year in Los Angeles and simultaneously took stand-up comedy classes. I started performing at local clubs around town throughout residency, and I had two or three good sets that I could rely on. And so that’s how I got into stand-up comedy.

My intern year is also when I started this social media satire account. It was a way to cope with the anxieties and stress of residency. Before I knew it, the account gained multitudes of followers, doctors, and other medical professionals. And I joke that the more hours I work in a week, the more memes I make, the more posts I make. It’s kind of a creative outlet for me after a long day.
 

Q: What types of things do you talk about during your stand-up act?

Dr. Haghighat: A lot of it is about growing up in an immigrant household as a first-generation Iranian American. One of my favorite jokes is, my parents gave me so many options for a career. They said I could be a family doctor, a surgeon, a plastic surgeon, and if I worked hard, even a wife of a surgeon. But I talk a lot about being a woman in medicine. That always gets a lot of laughs. And now that I’ve graduated GI fellowship, I’m excited to incorporate some GI jokes because it turns out people love poop jokes.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

Denver

Cat or dog person

Dog

Best place you went on vacation

Patagonia

Favorite sport

Basketball

Favorite ice cream

Rocky Road

What song do you have to sing along with when you hear it?

Celine Dion’s My Heart Will Go On

Growing up in a household where GI issues dominated conversations, it’s no surprise that Shida Haghighat, MD, chose gastroenterology as her area of study in medicine.

She watched her father suffer from the complications of Crohn’s disease and her brother struggle with irritable bowel syndrome. “We always needed to know where the nearest bathroom was. I grew up with that around me, and I was always just fascinated by the gut and the digestive system,” said Dr. Haghighat, who just finished up her fellowship at the University of Miami and is now a gastroenterologist at University of California, Los Angeles. She also serves as social media editor for AGA’s Gastro Hep Advances.

Haghighat_Shida_CA_web.jpg

As she got to know the personalities of the GI department in the first year of medical school, “I realized that our senses of humor and personalities kind of aligned, and I was like, ‘Oh yeah, this is where I’m supposed to be,’ ” said Dr. Haghighat, who can be found on X @DoctorShida.

Humor is something Dr. Haghighat has reached for throughout her life and career. She eventually channeled her gift for satire onto the stage and the internet, as a stand-up comedian. In an interview with GI & Hepatology News, she spoke about the connection between GI medicine and humor, and the creative ways she has helped promote cancer screening in underserved populations.
 

Q: What practice challenges have you faced in your career?

Dr. Haghighat: I trained in a county hospital, so I’ve always worked with underserved and vulnerable populations. One of the challenges has been just navigation of care, especially as it pertains to cancer diagnoses or cancer screening. A lot of the time, patients don’t understand why they have to do a test or something invasive like a colonoscopy for symptoms they don’t have. 

Q: A focus of yours has been improving uptake of screening in underserved communities. Please talk about the work you’ve done in this area.

Dr. Haghighat: I was at Los Angeles General Medical Center — a county hospital in Los Angeles — for residency, where we treated underserved, uninsured patients. I noticed in our primary care clinics a very low uptake of colon cancer screening. Patients didn’t want to bring the stool tests back or get colonoscopies. I surveyed a bunch of the patients and asked: How can we make colon cancer screening easier for you? About a third of the patients said, “If I can do it in the clinic before I go home, that would be great.”

So, I started this initiative called “Go Before You Go.” We would ask patients, “Hey, do you need to go to the bathroom right now, if you can?” Our nurses handed them the stool test to do in the bathroom before they left the clinic after their doctor visits.

We saw really good results with that. Surprisingly, a lot of people can go on demand. We saw increased screening rates, and that quality improvement project went on to win multiple first place awards in research competitions. So that’s what got me interested, and that’s where I had my beginnings of increasing preventative services in underserved communities on the ground.
 

Q: Can you discuss some health disparity studies you’ve done in this area?

Dr. Haghighat: As a GI at Jackson Memorial Hospital in Miami, I was seeing cancer disparities firsthand every day. I wanted to approach these disparities from a research funding standpoint on a federal level. I was particularly interested in gastric cancer because it’s not common enough in the United States to warrant universal screening, but it’s very common among certain racial and ethnic minorities, which would warrant targeted screening.

I evaluated cancer funding allocation from the National Cancer Institute among the most common cancers in the United States and found that cancer afflicting a higher proportion of racial and ethnic minorities was receiving lower funding. One of those cancers was stomach cancer. This study basically highlighted that, to decrease these disparities, a top-down policy approach is necessary to distribute cancer research funding equitably across these groups. 

A lot of stomach cancer comes from a bacteria called Helicobacter pylori, which can be more prevalent in certain countries. In another study, I looked at country of birth as a risk factor for stomach cancer, specifically for gastric intestinal metaplasia, which is a precursor for gastric cancer . 

We found that country of birth is a key risk factor for gastric intestinal metaplasia and that it should be incorporated into risk stratification for targeted screening. 
 

Q: Outside of medicine, you perform as a stand-up comedian. You have a popular satirical alias on social media. How did you get interested in stand-up comedy?

Dr. Haghighat: I gave my medical school’s commencement speech, and I had sprinkled a few jokes in there. Afterward, multiple people approached me and said, “You should really consider stand-up comedy. Your timing and delivery are great.” A few months later, I started my intern year in Los Angeles and simultaneously took stand-up comedy classes. I started performing at local clubs around town throughout residency, and I had two or three good sets that I could rely on. And so that’s how I got into stand-up comedy.

My intern year is also when I started this social media satire account. It was a way to cope with the anxieties and stress of residency. Before I knew it, the account gained multitudes of followers, doctors, and other medical professionals. And I joke that the more hours I work in a week, the more memes I make, the more posts I make. It’s kind of a creative outlet for me after a long day.
 

Q: What types of things do you talk about during your stand-up act?

Dr. Haghighat: A lot of it is about growing up in an immigrant household as a first-generation Iranian American. One of my favorite jokes is, my parents gave me so many options for a career. They said I could be a family doctor, a surgeon, a plastic surgeon, and if I worked hard, even a wife of a surgeon. But I talk a lot about being a woman in medicine. That always gets a lot of laughs. And now that I’ve graduated GI fellowship, I’m excited to incorporate some GI jokes because it turns out people love poop jokes.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

Denver

Cat or dog person

Dog

Best place you went on vacation

Patagonia

Favorite sport

Basketball

Favorite ice cream

Rocky Road

What song do you have to sing along with when you hear it?

Celine Dion’s My Heart Will Go On

Growing up in a household where GI issues dominated conversations, it’s no surprise that Shida Haghighat, MD, chose gastroenterology as her area of study in medicine.

She watched her father suffer from the complications of Crohn’s disease and her brother struggle with irritable bowel syndrome. “We always needed to know where the nearest bathroom was. I grew up with that around me, and I was always just fascinated by the gut and the digestive system,” said Dr. Haghighat, who just finished up her fellowship at the University of Miami and is now a gastroenterologist at University of California, Los Angeles. She also serves as social media editor for AGA’s Gastro Hep Advances.

Haghighat_Shida_CA_web.jpg

As she got to know the personalities of the GI department in the first year of medical school, “I realized that our senses of humor and personalities kind of aligned, and I was like, ‘Oh yeah, this is where I’m supposed to be,’ ” said Dr. Haghighat, who can be found on X @DoctorShida.

Humor is something Dr. Haghighat has reached for throughout her life and career. She eventually channeled her gift for satire onto the stage and the internet, as a stand-up comedian. In an interview with GI & Hepatology News, she spoke about the connection between GI medicine and humor, and the creative ways she has helped promote cancer screening in underserved populations.
 

Q: What practice challenges have you faced in your career?

Dr. Haghighat: I trained in a county hospital, so I’ve always worked with underserved and vulnerable populations. One of the challenges has been just navigation of care, especially as it pertains to cancer diagnoses or cancer screening. A lot of the time, patients don’t understand why they have to do a test or something invasive like a colonoscopy for symptoms they don’t have. 

Q: A focus of yours has been improving uptake of screening in underserved communities. Please talk about the work you’ve done in this area.

Dr. Haghighat: I was at Los Angeles General Medical Center — a county hospital in Los Angeles — for residency, where we treated underserved, uninsured patients. I noticed in our primary care clinics a very low uptake of colon cancer screening. Patients didn’t want to bring the stool tests back or get colonoscopies. I surveyed a bunch of the patients and asked: How can we make colon cancer screening easier for you? About a third of the patients said, “If I can do it in the clinic before I go home, that would be great.”

So, I started this initiative called “Go Before You Go.” We would ask patients, “Hey, do you need to go to the bathroom right now, if you can?” Our nurses handed them the stool test to do in the bathroom before they left the clinic after their doctor visits.

We saw really good results with that. Surprisingly, a lot of people can go on demand. We saw increased screening rates, and that quality improvement project went on to win multiple first place awards in research competitions. So that’s what got me interested, and that’s where I had my beginnings of increasing preventative services in underserved communities on the ground.
 

Q: Can you discuss some health disparity studies you’ve done in this area?

Dr. Haghighat: As a GI at Jackson Memorial Hospital in Miami, I was seeing cancer disparities firsthand every day. I wanted to approach these disparities from a research funding standpoint on a federal level. I was particularly interested in gastric cancer because it’s not common enough in the United States to warrant universal screening, but it’s very common among certain racial and ethnic minorities, which would warrant targeted screening.

I evaluated cancer funding allocation from the National Cancer Institute among the most common cancers in the United States and found that cancer afflicting a higher proportion of racial and ethnic minorities was receiving lower funding. One of those cancers was stomach cancer. This study basically highlighted that, to decrease these disparities, a top-down policy approach is necessary to distribute cancer research funding equitably across these groups. 

A lot of stomach cancer comes from a bacteria called Helicobacter pylori, which can be more prevalent in certain countries. In another study, I looked at country of birth as a risk factor for stomach cancer, specifically for gastric intestinal metaplasia, which is a precursor for gastric cancer . 

We found that country of birth is a key risk factor for gastric intestinal metaplasia and that it should be incorporated into risk stratification for targeted screening. 
 

Q: Outside of medicine, you perform as a stand-up comedian. You have a popular satirical alias on social media. How did you get interested in stand-up comedy?

Dr. Haghighat: I gave my medical school’s commencement speech, and I had sprinkled a few jokes in there. Afterward, multiple people approached me and said, “You should really consider stand-up comedy. Your timing and delivery are great.” A few months later, I started my intern year in Los Angeles and simultaneously took stand-up comedy classes. I started performing at local clubs around town throughout residency, and I had two or three good sets that I could rely on. And so that’s how I got into stand-up comedy.

My intern year is also when I started this social media satire account. It was a way to cope with the anxieties and stress of residency. Before I knew it, the account gained multitudes of followers, doctors, and other medical professionals. And I joke that the more hours I work in a week, the more memes I make, the more posts I make. It’s kind of a creative outlet for me after a long day.
 

Q: What types of things do you talk about during your stand-up act?

Dr. Haghighat: A lot of it is about growing up in an immigrant household as a first-generation Iranian American. One of my favorite jokes is, my parents gave me so many options for a career. They said I could be a family doctor, a surgeon, a plastic surgeon, and if I worked hard, even a wife of a surgeon. But I talk a lot about being a woman in medicine. That always gets a lot of laughs. And now that I’ve graduated GI fellowship, I’m excited to incorporate some GI jokes because it turns out people love poop jokes.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

Denver

Cat or dog person

Dog

Best place you went on vacation

Patagonia

Favorite sport

Basketball

Favorite ice cream

Rocky Road

What song do you have to sing along with when you hear it?

Celine Dion’s My Heart Will Go On

Blood-based screening for colorectal cancer (CRC), also known as a “liquid biopsy,” may be better than nothing among patients who skip established screening tests, but it can’t replace colonoscopy as the gold standard, according to two new modeling studies and an expert consensus commentary.

Although some patients find blood-based tests more convenient, the higher numbers of false positives and false negatives could lead to more CRC cases and deaths.

“Based on their current characteristics, blood tests should not be recommended to replace established colorectal cancer screening tests, since blood tests are neither as effective nor cost-effective and would worsen outcomes,” David Lieberman, MD, AGAF, chair of the American Gastroenterological Association’s CRC Workshop Panel, and lead author of the expert commentary, said in a statement.

Lieberman_David_Ore_web.jpg

The blood tests detect circulating nucleotides, such as cell-free DNA or metabolic products associated with CRC and its precursors. Current tests are in development by Guardant Health and Freenome.

The two modeling studies, published in Gastroenterology on March 26, analyzed the effectiveness and cost-effectiveness of blood-based CRC screening that meets Centers for Medicare & Medicaid Services (CMS) coverage criteria, as well as the comparative effectiveness and cost-effectiveness of CRC screening with blood-based biomarkers versus fecal tests or colonoscopy.

Also published on March 26 in Clinical Gastroenterology and Hepatology, the expert commentary included key conclusions from the AGA CRC Workshop, which analyzed the two modeling studies.
 

Comparing CRC Screening Methods

In the first modeling study, an international team of researchers ran three microsimulation models for CRC to estimate the effectiveness and cost-effectiveness of triennial blood-based screening for ages 45-75, compared with no screening, annual fecal immunochemical testing (FIT), triennial stool DNA testing combined with a FIT assay, and colonoscopy screening every 10 years. The researchers used CMS coverage criteria for blood tests, with a sensitivity of at least 74% for detection of CRC and specificity of at least 90%.

Without screening, the models predicted between 77 and 88 CRC cases and between 32 and 36 deaths per 1,000 individuals, costing between $5.3 million to $5.8 million. Compared with no screening, blood-based screening was considered cost-effective, with an additional cost of $25,600 to $43,700 per quality-adjusted life-year gained (QALYG).

However, compared with the FIT, stool, and colonoscopy options, blood-based screening was not cost-effective, with both a decrease in QALYG and an increase in costs. FIT was more effective and less costly, with 5-24 QALYG and nearly $3.5 million cheaper than blood-based screening, even when blood-based uptake was 20 percentage points higher than FIT uptake.

In the second modeling study, US researchers compared triennial blood-based screening with established alternatives at the CMS thresholds of 74% sensitivity and 90% specificity.

Overall, a blood-based test at the CMS minimum reduced CRC incidence by 40% and CRC mortality by 52% versus no screening. However, a blood-based test was significantly less effective than triennial stool DNA testing, annual FIT, and colonoscopy every 10 years, which reduced CRC incidence by 68%-79% and CRC mortality by 73%-81%.

Assuming a blood-based test would cost the same as a multi-target stool test, the blood-based test would cost $28,500 per QALYG versus no screening. At the same time, FIT, colonoscopy, and stool DNA testing were less costly and more effective. In general, the blood-based test would match FIT’s clinical outcomes if it achieved 1.4- to 1.8-fold the participation rate for FIT.

Even still, the sensitivity for advanced precancerous lesion (APL) was a key determinant. A paradigm-changing blood-based test would need to have higher than 90% sensitivity for CRC and 80% for APL, 90% specificity, and cost less than $120 to $140, the study authors wrote.

“High APL sensitivity, which can result in CRC prevention, should be a top priority for screening test developers,” the authors wrote. “APL detection should not be penalized by a definition of test specificity that focuses on CRC only.”
 

Additional Considerations

The AGA CRC Workshop Panel met in September 2023 to review the two modeling studies and other data on blood-based tests for CRC. Overall, the group concluded that a triennial blood test that meets minimal CMS criteria would likely result in better outcomes than no screening and provide a simple process to encourage more people to participate in screening.

However, patients who may have declined colonoscopy should understand the need for a colonoscopy if blood-based tests show abnormal results, the commentary authors wrote.

In addition, because blood-based tests for CRC appear to be less effective and more costly than current screening options, they shouldn’t be recommended to replace established screening methods. Although these blood-based tests may improve screening rates and outcomes in unscreened people, substituting blood tests for other effective tests would increase costs and worsen patient outcomes.

Beyond that, they wrote, the industry should consider other potential benchmarks for an effective blood test, such as a sensitivity for stage I-III CRC of greater than 90% and sensitivity for advanced adenomas of 40%-50% or higher.

Carethers_John_CA.jpg

“Unless we have the expectation of high sensitivity and specificity, blood-based colorectal cancer tests could lead to false positive and false negative results, which are both bad for patient outcomes,” John M. Carethers, MD, AGAF, vice chancellor for health sciences at UC San Diego, AGA past president, and a member of the AGA CRC Workshop panel, said in a statement.

Several authors reported consultant roles and funding support from numerous companies, including Guardant Health and Freenome.

Blood-based screening for colorectal cancer (CRC), also known as a “liquid biopsy,” may be better than nothing among patients who skip established screening tests, but it can’t replace colonoscopy as the gold standard, according to two new modeling studies and an expert consensus commentary.

Although some patients find blood-based tests more convenient, the higher numbers of false positives and false negatives could lead to more CRC cases and deaths.

“Based on their current characteristics, blood tests should not be recommended to replace established colorectal cancer screening tests, since blood tests are neither as effective nor cost-effective and would worsen outcomes,” David Lieberman, MD, AGAF, chair of the American Gastroenterological Association’s CRC Workshop Panel, and lead author of the expert commentary, said in a statement.

Lieberman_David_Ore_web.jpg

The blood tests detect circulating nucleotides, such as cell-free DNA or metabolic products associated with CRC and its precursors. Current tests are in development by Guardant Health and Freenome.

The two modeling studies, published in Gastroenterology on March 26, analyzed the effectiveness and cost-effectiveness of blood-based CRC screening that meets Centers for Medicare & Medicaid Services (CMS) coverage criteria, as well as the comparative effectiveness and cost-effectiveness of CRC screening with blood-based biomarkers versus fecal tests or colonoscopy.

Also published on March 26 in Clinical Gastroenterology and Hepatology, the expert commentary included key conclusions from the AGA CRC Workshop, which analyzed the two modeling studies.
 

Comparing CRC Screening Methods

In the first modeling study, an international team of researchers ran three microsimulation models for CRC to estimate the effectiveness and cost-effectiveness of triennial blood-based screening for ages 45-75, compared with no screening, annual fecal immunochemical testing (FIT), triennial stool DNA testing combined with a FIT assay, and colonoscopy screening every 10 years. The researchers used CMS coverage criteria for blood tests, with a sensitivity of at least 74% for detection of CRC and specificity of at least 90%.

Without screening, the models predicted between 77 and 88 CRC cases and between 32 and 36 deaths per 1,000 individuals, costing between $5.3 million to $5.8 million. Compared with no screening, blood-based screening was considered cost-effective, with an additional cost of $25,600 to $43,700 per quality-adjusted life-year gained (QALYG).

However, compared with the FIT, stool, and colonoscopy options, blood-based screening was not cost-effective, with both a decrease in QALYG and an increase in costs. FIT was more effective and less costly, with 5-24 QALYG and nearly $3.5 million cheaper than blood-based screening, even when blood-based uptake was 20 percentage points higher than FIT uptake.

In the second modeling study, US researchers compared triennial blood-based screening with established alternatives at the CMS thresholds of 74% sensitivity and 90% specificity.

Overall, a blood-based test at the CMS minimum reduced CRC incidence by 40% and CRC mortality by 52% versus no screening. However, a blood-based test was significantly less effective than triennial stool DNA testing, annual FIT, and colonoscopy every 10 years, which reduced CRC incidence by 68%-79% and CRC mortality by 73%-81%.

Assuming a blood-based test would cost the same as a multi-target stool test, the blood-based test would cost $28,500 per QALYG versus no screening. At the same time, FIT, colonoscopy, and stool DNA testing were less costly and more effective. In general, the blood-based test would match FIT’s clinical outcomes if it achieved 1.4- to 1.8-fold the participation rate for FIT.

Even still, the sensitivity for advanced precancerous lesion (APL) was a key determinant. A paradigm-changing blood-based test would need to have higher than 90% sensitivity for CRC and 80% for APL, 90% specificity, and cost less than $120 to $140, the study authors wrote.

“High APL sensitivity, which can result in CRC prevention, should be a top priority for screening test developers,” the authors wrote. “APL detection should not be penalized by a definition of test specificity that focuses on CRC only.”
 

Additional Considerations

The AGA CRC Workshop Panel met in September 2023 to review the two modeling studies and other data on blood-based tests for CRC. Overall, the group concluded that a triennial blood test that meets minimal CMS criteria would likely result in better outcomes than no screening and provide a simple process to encourage more people to participate in screening.

However, patients who may have declined colonoscopy should understand the need for a colonoscopy if blood-based tests show abnormal results, the commentary authors wrote.

In addition, because blood-based tests for CRC appear to be less effective and more costly than current screening options, they shouldn’t be recommended to replace established screening methods. Although these blood-based tests may improve screening rates and outcomes in unscreened people, substituting blood tests for other effective tests would increase costs and worsen patient outcomes.

Beyond that, they wrote, the industry should consider other potential benchmarks for an effective blood test, such as a sensitivity for stage I-III CRC of greater than 90% and sensitivity for advanced adenomas of 40%-50% or higher.

Carethers_John_CA.jpg

“Unless we have the expectation of high sensitivity and specificity, blood-based colorectal cancer tests could lead to false positive and false negative results, which are both bad for patient outcomes,” John M. Carethers, MD, AGAF, vice chancellor for health sciences at UC San Diego, AGA past president, and a member of the AGA CRC Workshop panel, said in a statement.

Several authors reported consultant roles and funding support from numerous companies, including Guardant Health and Freenome.

Blood-based screening for colorectal cancer (CRC), also known as a “liquid biopsy,” may be better than nothing among patients who skip established screening tests, but it can’t replace colonoscopy as the gold standard, according to two new modeling studies and an expert consensus commentary.

Although some patients find blood-based tests more convenient, the higher numbers of false positives and false negatives could lead to more CRC cases and deaths.

“Based on their current characteristics, blood tests should not be recommended to replace established colorectal cancer screening tests, since blood tests are neither as effective nor cost-effective and would worsen outcomes,” David Lieberman, MD, AGAF, chair of the American Gastroenterological Association’s CRC Workshop Panel, and lead author of the expert commentary, said in a statement.

Lieberman_David_Ore_web.jpg

The blood tests detect circulating nucleotides, such as cell-free DNA or metabolic products associated with CRC and its precursors. Current tests are in development by Guardant Health and Freenome.

The two modeling studies, published in Gastroenterology on March 26, analyzed the effectiveness and cost-effectiveness of blood-based CRC screening that meets Centers for Medicare & Medicaid Services (CMS) coverage criteria, as well as the comparative effectiveness and cost-effectiveness of CRC screening with blood-based biomarkers versus fecal tests or colonoscopy.

Also published on March 26 in Clinical Gastroenterology and Hepatology, the expert commentary included key conclusions from the AGA CRC Workshop, which analyzed the two modeling studies.
 

Comparing CRC Screening Methods

In the first modeling study, an international team of researchers ran three microsimulation models for CRC to estimate the effectiveness and cost-effectiveness of triennial blood-based screening for ages 45-75, compared with no screening, annual fecal immunochemical testing (FIT), triennial stool DNA testing combined with a FIT assay, and colonoscopy screening every 10 years. The researchers used CMS coverage criteria for blood tests, with a sensitivity of at least 74% for detection of CRC and specificity of at least 90%.

Without screening, the models predicted between 77 and 88 CRC cases and between 32 and 36 deaths per 1,000 individuals, costing between $5.3 million to $5.8 million. Compared with no screening, blood-based screening was considered cost-effective, with an additional cost of $25,600 to $43,700 per quality-adjusted life-year gained (QALYG).

However, compared with the FIT, stool, and colonoscopy options, blood-based screening was not cost-effective, with both a decrease in QALYG and an increase in costs. FIT was more effective and less costly, with 5-24 QALYG and nearly $3.5 million cheaper than blood-based screening, even when blood-based uptake was 20 percentage points higher than FIT uptake.

In the second modeling study, US researchers compared triennial blood-based screening with established alternatives at the CMS thresholds of 74% sensitivity and 90% specificity.

Overall, a blood-based test at the CMS minimum reduced CRC incidence by 40% and CRC mortality by 52% versus no screening. However, a blood-based test was significantly less effective than triennial stool DNA testing, annual FIT, and colonoscopy every 10 years, which reduced CRC incidence by 68%-79% and CRC mortality by 73%-81%.

Assuming a blood-based test would cost the same as a multi-target stool test, the blood-based test would cost $28,500 per QALYG versus no screening. At the same time, FIT, colonoscopy, and stool DNA testing were less costly and more effective. In general, the blood-based test would match FIT’s clinical outcomes if it achieved 1.4- to 1.8-fold the participation rate for FIT.

Even still, the sensitivity for advanced precancerous lesion (APL) was a key determinant. A paradigm-changing blood-based test would need to have higher than 90% sensitivity for CRC and 80% for APL, 90% specificity, and cost less than $120 to $140, the study authors wrote.

“High APL sensitivity, which can result in CRC prevention, should be a top priority for screening test developers,” the authors wrote. “APL detection should not be penalized by a definition of test specificity that focuses on CRC only.”
 

Additional Considerations

The AGA CRC Workshop Panel met in September 2023 to review the two modeling studies and other data on blood-based tests for CRC. Overall, the group concluded that a triennial blood test that meets minimal CMS criteria would likely result in better outcomes than no screening and provide a simple process to encourage more people to participate in screening.

However, patients who may have declined colonoscopy should understand the need for a colonoscopy if blood-based tests show abnormal results, the commentary authors wrote.

In addition, because blood-based tests for CRC appear to be less effective and more costly than current screening options, they shouldn’t be recommended to replace established screening methods. Although these blood-based tests may improve screening rates and outcomes in unscreened people, substituting blood tests for other effective tests would increase costs and worsen patient outcomes.

Beyond that, they wrote, the industry should consider other potential benchmarks for an effective blood test, such as a sensitivity for stage I-III CRC of greater than 90% and sensitivity for advanced adenomas of 40%-50% or higher.

Carethers_John_CA.jpg

“Unless we have the expectation of high sensitivity and specificity, blood-based colorectal cancer tests could lead to false positive and false negative results, which are both bad for patient outcomes,” John M. Carethers, MD, AGAF, vice chancellor for health sciences at UC San Diego, AGA past president, and a member of the AGA CRC Workshop panel, said in a statement.

Several authors reported consultant roles and funding support from numerous companies, including Guardant Health and Freenome.

A next-generation stool DNA test for colorectal cancer (CRC) screening had higher sensitivity for all screening-relevant lesions but lower specificity than a currently available fecal immunochemical test (FIT), according to the large prospective BLUE-C study.

The multi-target assay by Exact Sciences Corporation, the makers of Cologuard, includes new biomarkers designed to increase specificity without decreasing sensitivity. It showed a sensitivity for CRC of almost 94%, with more than 43% sensitivity for advanced precancerous lesions and nearly 91% specificity for advanced neoplasia, according to the study results, which were published in The New England Journal of Medicine.

Imperiale_Thomas_IN_web.jpg

Adherence to CRC screening in the United States is well below the 80% national target, and the quest continues for noninvasive screening assays that might improve screening adherence, noted lead author Thomas F. Imperiale, MD, AGAF, a professor of medicine at Indiana University School of medicine in Indianapolis, and colleagues.

“The test’s manufacturer developed a new version of its existing Cologuard FIT/DNA test because it took to heart the feedback from primary care providers and gastroenterologists about the test’s low specificity,” Dr. Imperiale said in an interview. “The goal of the new test was to improve specificity without losing, and perhaps even gaining, some sensitivity — a goal that is not easily accomplished when you’re trying to improve on a sensitivity for colorectal cancer that was already 92.3% in the current version of Cologuard.”

Compared with the earlier version of Cologuard, he added, the new generation retained sensitivity for CRC and advanced precancerous lesions or polyps while improving specificity by 30% (90.6% vs 86.6%) for advanced neoplasia — a combination of CRC and advanced precancerous lesions, he said. “This with the caveat, however, that the two versions were not compared head-to-head in this new study,” Dr. Imperiale said.

The higher specificity for advanced lesions is expected to translate to a lower false positive rate. Lowering false positive rates is crucial because that reduces the need for costly, invasive, and unnecessary colonoscopies, said Aasma Shaukat, MD, MPH, AGAF, director of outcomes research in NYU Langone Health’s division of gastroenterology and hepatology in New York City.

Shaukat_Aasma_NY_web.jpg

“Many physicians felt there were too many false positives with the existing version, and that is anxiety-provoking in patients and providers,” said Dr. Shaukat, who was not involved in the study.

In her view, however, the test’s moderate improvements in detecting certain lesions does not make it demonstrably superior to its predecessor, and there is always the possibility of higher cost to consider.

While acknowledging that a higher sensitivity for all advanced precancerous lesions would have been welcome, Dr. Imperiale said the test detected 75% of the most worrisome of such lesions — “the ones containing high-grade dysplastic cells and suggesting near-term conversion to cancer. And its ability to detect other advanced lesions improved as the size of the lesions increased.”
 

Testing details

Almost 21,000 asymptomatic participants age 40 years and older undergoing screening colonoscopy were evaluated at 186 US sites during the period 2019 to 2023. Of the cohort, 98 had CRC, 2144 had advanced precancerous lesions, 6973 had nonadvanced adenomas, and 10,961 had nonneoplastic findings or negative colonoscopy.

Advanced precancerous lesions included one or more adenomas or sessile serrated lesions measuring at least 1 cm in the longest dimension, lesions with villous histologic features, and high-grade dysplasia. The new DNA test identified 92 of 98 participants with CRC and 76 of 82 participants with screening-relevant cancers. Among the findings for the new assay:

• Sensitivity for any-stage CRC was 93.9% (95% confidence interval [CI], 87.1- 97.7)
• Sensitivity for advanced precancerous lesions was 43.4% (95% CI, 41.3-45.6)
• Sensitivity for high-grade dysplasia was 74.6% (95% CI, 65.6-82.3)
• Specificity for advanced neoplasia was 90.6% (95% CI, 90.1- 91.0).
• Specificity for nonneoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2-93.1)
• Specificity for negative colonoscopy was 93.3 (95% CI, 92.8-93.9)
• No adverse events occurred.

In the comparator assay, OC-AUTO FIT by Polymedco, sensitivity was 67.3% (95% CI, 57.1-76.5) for CRC, 23.3% (95% CI, 21.5-25.2) for advanced precancerous lesions, and 47.4% (95% CI, 37.9-56.9) for high-grade dysplasia. In the comparator FIT, however, specificity was better across all age groups — at 94.8% (95% CI, 94.4-95.1) for advanced neoplasia, 95.7% (95% CI, 95.3- 96.1) for nonneoplastic findings, and 96.0% (95% CI, 95.5-96.4) for negative colonoscopy.

In another article in the same issue of NEJM, Guardant Health’s cell-free DNA blood-based test had 83% sensitivity for CRC, 90% specificity for advanced neoplasia, and 13% sensitivity for advanced precancerous lesions in an average-risk population.

An age-related decrease in specificity was observed with the new Cologuard test, but that did not concern Dr. Imperiale because the same observation was made with the current version. “In fact, the next-gen version appears to have less of an age-related decrease in specificity than the current version, although, again, the two versions were not tested head-to-head,” he noted.

The effect of age-related background methylation of DNA is well known, he explained. “Clinicians and older patients in the screening age range do need to be aware of this effect on specificity before ordering or agreeing to do the test. I do not see this as a stumbling block to implementation, but it does require discussion between patient and ordering provider.”

The new version of the DNA test is expected to be available in about a year.

According to Dr. Imperiale, further research is needed to ascertain the test’s acceptability and adherence rates and to quantify its yield in population-based screening. Determining its cost-effectiveness and making it easier to use are other goals. “And most importantly, the degree of reduction in the incidence and mortality from colorectal cancer,” he said.

Cost-effectiveness and the selection of the testing interval may play roles in adherence, particularly in populations with lower rates of screening adherence than the general population, John M. Carethers, MD, AGAF, of the University of California, San Diego, noted in a related editorial.

“Adherence to screening varies according to age group, including persons in the 45- to 49-year age group who are now eligible for average-risk screening,” he wrote. “It is hoped that these newer tests will increase use and adherence and elevate the percentage of the population undergoing screening in order to reduce deaths from colorectal cancer.”

This study was sponsored by Exact Sciences Corporation, which conducted the stool testing at its laboratories.

Dr. Imperiale had no competing interests to disclose. Several study co-authors reported employment with Exact Sciences, or stock and intellectual property ownership. Dr. Shaukat disclosed consulting for Freenome. Dr. Carethers reported ties to Avantor Inc. and Geneoscopy.

A next-generation stool DNA test for colorectal cancer (CRC) screening had higher sensitivity for all screening-relevant lesions but lower specificity than a currently available fecal immunochemical test (FIT), according to the large prospective BLUE-C study.

The multi-target assay by Exact Sciences Corporation, the makers of Cologuard, includes new biomarkers designed to increase specificity without decreasing sensitivity. It showed a sensitivity for CRC of almost 94%, with more than 43% sensitivity for advanced precancerous lesions and nearly 91% specificity for advanced neoplasia, according to the study results, which were published in The New England Journal of Medicine.

Imperiale_Thomas_IN_web.jpg

Adherence to CRC screening in the United States is well below the 80% national target, and the quest continues for noninvasive screening assays that might improve screening adherence, noted lead author Thomas F. Imperiale, MD, AGAF, a professor of medicine at Indiana University School of medicine in Indianapolis, and colleagues.

“The test’s manufacturer developed a new version of its existing Cologuard FIT/DNA test because it took to heart the feedback from primary care providers and gastroenterologists about the test’s low specificity,” Dr. Imperiale said in an interview. “The goal of the new test was to improve specificity without losing, and perhaps even gaining, some sensitivity — a goal that is not easily accomplished when you’re trying to improve on a sensitivity for colorectal cancer that was already 92.3% in the current version of Cologuard.”

Compared with the earlier version of Cologuard, he added, the new generation retained sensitivity for CRC and advanced precancerous lesions or polyps while improving specificity by 30% (90.6% vs 86.6%) for advanced neoplasia — a combination of CRC and advanced precancerous lesions, he said. “This with the caveat, however, that the two versions were not compared head-to-head in this new study,” Dr. Imperiale said.

The higher specificity for advanced lesions is expected to translate to a lower false positive rate. Lowering false positive rates is crucial because that reduces the need for costly, invasive, and unnecessary colonoscopies, said Aasma Shaukat, MD, MPH, AGAF, director of outcomes research in NYU Langone Health’s division of gastroenterology and hepatology in New York City.

Shaukat_Aasma_NY_web.jpg

“Many physicians felt there were too many false positives with the existing version, and that is anxiety-provoking in patients and providers,” said Dr. Shaukat, who was not involved in the study.

In her view, however, the test’s moderate improvements in detecting certain lesions does not make it demonstrably superior to its predecessor, and there is always the possibility of higher cost to consider.

While acknowledging that a higher sensitivity for all advanced precancerous lesions would have been welcome, Dr. Imperiale said the test detected 75% of the most worrisome of such lesions — “the ones containing high-grade dysplastic cells and suggesting near-term conversion to cancer. And its ability to detect other advanced lesions improved as the size of the lesions increased.”
 

Testing details

Almost 21,000 asymptomatic participants age 40 years and older undergoing screening colonoscopy were evaluated at 186 US sites during the period 2019 to 2023. Of the cohort, 98 had CRC, 2144 had advanced precancerous lesions, 6973 had nonadvanced adenomas, and 10,961 had nonneoplastic findings or negative colonoscopy.

Advanced precancerous lesions included one or more adenomas or sessile serrated lesions measuring at least 1 cm in the longest dimension, lesions with villous histologic features, and high-grade dysplasia. The new DNA test identified 92 of 98 participants with CRC and 76 of 82 participants with screening-relevant cancers. Among the findings for the new assay:

• Sensitivity for any-stage CRC was 93.9% (95% confidence interval [CI], 87.1- 97.7)
• Sensitivity for advanced precancerous lesions was 43.4% (95% CI, 41.3-45.6)
• Sensitivity for high-grade dysplasia was 74.6% (95% CI, 65.6-82.3)
• Specificity for advanced neoplasia was 90.6% (95% CI, 90.1- 91.0).
• Specificity for nonneoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2-93.1)
• Specificity for negative colonoscopy was 93.3 (95% CI, 92.8-93.9)
• No adverse events occurred.

In the comparator assay, OC-AUTO FIT by Polymedco, sensitivity was 67.3% (95% CI, 57.1-76.5) for CRC, 23.3% (95% CI, 21.5-25.2) for advanced precancerous lesions, and 47.4% (95% CI, 37.9-56.9) for high-grade dysplasia. In the comparator FIT, however, specificity was better across all age groups — at 94.8% (95% CI, 94.4-95.1) for advanced neoplasia, 95.7% (95% CI, 95.3- 96.1) for nonneoplastic findings, and 96.0% (95% CI, 95.5-96.4) for negative colonoscopy.

In another article in the same issue of NEJM, Guardant Health’s cell-free DNA blood-based test had 83% sensitivity for CRC, 90% specificity for advanced neoplasia, and 13% sensitivity for advanced precancerous lesions in an average-risk population.

An age-related decrease in specificity was observed with the new Cologuard test, but that did not concern Dr. Imperiale because the same observation was made with the current version. “In fact, the next-gen version appears to have less of an age-related decrease in specificity than the current version, although, again, the two versions were not tested head-to-head,” he noted.

The effect of age-related background methylation of DNA is well known, he explained. “Clinicians and older patients in the screening age range do need to be aware of this effect on specificity before ordering or agreeing to do the test. I do not see this as a stumbling block to implementation, but it does require discussion between patient and ordering provider.”

The new version of the DNA test is expected to be available in about a year.

According to Dr. Imperiale, further research is needed to ascertain the test’s acceptability and adherence rates and to quantify its yield in population-based screening. Determining its cost-effectiveness and making it easier to use are other goals. “And most importantly, the degree of reduction in the incidence and mortality from colorectal cancer,” he said.

Cost-effectiveness and the selection of the testing interval may play roles in adherence, particularly in populations with lower rates of screening adherence than the general population, John M. Carethers, MD, AGAF, of the University of California, San Diego, noted in a related editorial.

“Adherence to screening varies according to age group, including persons in the 45- to 49-year age group who are now eligible for average-risk screening,” he wrote. “It is hoped that these newer tests will increase use and adherence and elevate the percentage of the population undergoing screening in order to reduce deaths from colorectal cancer.”

This study was sponsored by Exact Sciences Corporation, which conducted the stool testing at its laboratories.

Dr. Imperiale had no competing interests to disclose. Several study co-authors reported employment with Exact Sciences, or stock and intellectual property ownership. Dr. Shaukat disclosed consulting for Freenome. Dr. Carethers reported ties to Avantor Inc. and Geneoscopy.

A next-generation stool DNA test for colorectal cancer (CRC) screening had higher sensitivity for all screening-relevant lesions but lower specificity than a currently available fecal immunochemical test (FIT), according to the large prospective BLUE-C study.

The multi-target assay by Exact Sciences Corporation, the makers of Cologuard, includes new biomarkers designed to increase specificity without decreasing sensitivity. It showed a sensitivity for CRC of almost 94%, with more than 43% sensitivity for advanced precancerous lesions and nearly 91% specificity for advanced neoplasia, according to the study results, which were published in The New England Journal of Medicine.

Imperiale_Thomas_IN_web.jpg

Adherence to CRC screening in the United States is well below the 80% national target, and the quest continues for noninvasive screening assays that might improve screening adherence, noted lead author Thomas F. Imperiale, MD, AGAF, a professor of medicine at Indiana University School of medicine in Indianapolis, and colleagues.

“The test’s manufacturer developed a new version of its existing Cologuard FIT/DNA test because it took to heart the feedback from primary care providers and gastroenterologists about the test’s low specificity,” Dr. Imperiale said in an interview. “The goal of the new test was to improve specificity without losing, and perhaps even gaining, some sensitivity — a goal that is not easily accomplished when you’re trying to improve on a sensitivity for colorectal cancer that was already 92.3% in the current version of Cologuard.”

Compared with the earlier version of Cologuard, he added, the new generation retained sensitivity for CRC and advanced precancerous lesions or polyps while improving specificity by 30% (90.6% vs 86.6%) for advanced neoplasia — a combination of CRC and advanced precancerous lesions, he said. “This with the caveat, however, that the two versions were not compared head-to-head in this new study,” Dr. Imperiale said.

The higher specificity for advanced lesions is expected to translate to a lower false positive rate. Lowering false positive rates is crucial because that reduces the need for costly, invasive, and unnecessary colonoscopies, said Aasma Shaukat, MD, MPH, AGAF, director of outcomes research in NYU Langone Health’s division of gastroenterology and hepatology in New York City.

Shaukat_Aasma_NY_web.jpg

“Many physicians felt there were too many false positives with the existing version, and that is anxiety-provoking in patients and providers,” said Dr. Shaukat, who was not involved in the study.

In her view, however, the test’s moderate improvements in detecting certain lesions does not make it demonstrably superior to its predecessor, and there is always the possibility of higher cost to consider.

While acknowledging that a higher sensitivity for all advanced precancerous lesions would have been welcome, Dr. Imperiale said the test detected 75% of the most worrisome of such lesions — “the ones containing high-grade dysplastic cells and suggesting near-term conversion to cancer. And its ability to detect other advanced lesions improved as the size of the lesions increased.”
 

Testing details

Almost 21,000 asymptomatic participants age 40 years and older undergoing screening colonoscopy were evaluated at 186 US sites during the period 2019 to 2023. Of the cohort, 98 had CRC, 2144 had advanced precancerous lesions, 6973 had nonadvanced adenomas, and 10,961 had nonneoplastic findings or negative colonoscopy.

Advanced precancerous lesions included one or more adenomas or sessile serrated lesions measuring at least 1 cm in the longest dimension, lesions with villous histologic features, and high-grade dysplasia. The new DNA test identified 92 of 98 participants with CRC and 76 of 82 participants with screening-relevant cancers. Among the findings for the new assay:

• Sensitivity for any-stage CRC was 93.9% (95% confidence interval [CI], 87.1- 97.7)
• Sensitivity for advanced precancerous lesions was 43.4% (95% CI, 41.3-45.6)
• Sensitivity for high-grade dysplasia was 74.6% (95% CI, 65.6-82.3)
• Specificity for advanced neoplasia was 90.6% (95% CI, 90.1- 91.0).
• Specificity for nonneoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2-93.1)
• Specificity for negative colonoscopy was 93.3 (95% CI, 92.8-93.9)
• No adverse events occurred.

In the comparator assay, OC-AUTO FIT by Polymedco, sensitivity was 67.3% (95% CI, 57.1-76.5) for CRC, 23.3% (95% CI, 21.5-25.2) for advanced precancerous lesions, and 47.4% (95% CI, 37.9-56.9) for high-grade dysplasia. In the comparator FIT, however, specificity was better across all age groups — at 94.8% (95% CI, 94.4-95.1) for advanced neoplasia, 95.7% (95% CI, 95.3- 96.1) for nonneoplastic findings, and 96.0% (95% CI, 95.5-96.4) for negative colonoscopy.

In another article in the same issue of NEJM, Guardant Health’s cell-free DNA blood-based test had 83% sensitivity for CRC, 90% specificity for advanced neoplasia, and 13% sensitivity for advanced precancerous lesions in an average-risk population.

An age-related decrease in specificity was observed with the new Cologuard test, but that did not concern Dr. Imperiale because the same observation was made with the current version. “In fact, the next-gen version appears to have less of an age-related decrease in specificity than the current version, although, again, the two versions were not tested head-to-head,” he noted.

The effect of age-related background methylation of DNA is well known, he explained. “Clinicians and older patients in the screening age range do need to be aware of this effect on specificity before ordering or agreeing to do the test. I do not see this as a stumbling block to implementation, but it does require discussion between patient and ordering provider.”

The new version of the DNA test is expected to be available in about a year.

According to Dr. Imperiale, further research is needed to ascertain the test’s acceptability and adherence rates and to quantify its yield in population-based screening. Determining its cost-effectiveness and making it easier to use are other goals. “And most importantly, the degree of reduction in the incidence and mortality from colorectal cancer,” he said.

Cost-effectiveness and the selection of the testing interval may play roles in adherence, particularly in populations with lower rates of screening adherence than the general population, John M. Carethers, MD, AGAF, of the University of California, San Diego, noted in a related editorial.

“Adherence to screening varies according to age group, including persons in the 45- to 49-year age group who are now eligible for average-risk screening,” he wrote. “It is hoped that these newer tests will increase use and adherence and elevate the percentage of the population undergoing screening in order to reduce deaths from colorectal cancer.”

This study was sponsored by Exact Sciences Corporation, which conducted the stool testing at its laboratories.

Dr. Imperiale had no competing interests to disclose. Several study co-authors reported employment with Exact Sciences, or stock and intellectual property ownership. Dr. Shaukat disclosed consulting for Freenome. Dr. Carethers reported ties to Avantor Inc. and Geneoscopy.