Colonoscopy vs Stool Testing for Older Adults With Colon Polyps

Recruiting now · Not applicable

Conditions studied: Colorectal Polyp, Colorectal Neoplasms, Colorectal Adenoma, Colorectal Cancer, Digestive System Disease

In brief

This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

Key facts

Study ID

NCT05612347

Run by

Dartmouth-Hitchcock Medical Center

People needed

8946

Starts

2023-06-14

Expected to finish

2035-12-31

Last updated by the study team

2026-07-14

Who can join

Age: 65 and older, up to 82. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English or Spanish speaking
• Personal history of colorectal polyps
• Most recent colonoscopy with ≤2 non-advanced polyps
• Currently due or coming due within 12 months for colonoscopy
• Able to provide written informed consent

You may not qualify if…

• Personal history of colorectal cancer
• Personal history of genetic syndrome with high risk for colorectal cancer (e.g. Lynch Syndrome, Familial Adenomatous Polyposis Syndrome (FAP), or Serrated Polyposis Syndrome)
• Personal history of inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease)
• Most recent colonoscopy with advanced polyp(s) or ≥3 non-advanced polyps
• Patients unlikely to benefit from polyp surveillance (e.g., history of heart disease or coronary artery disease with treatment in the last 6 months, heart failure affecting function, lung disease requiring use of home oxygen, stroke within the last 4 months, dementia affecting activities of daily living (ADL) or instrumental activities of daily living (IADL), severe liver disease requiring the use of certain medications to control fluid, confusion, or bleeding, severe kidney disease requiring dialysis, or a new cancer diagnosis within the last year)
• Patients unable to provide written informed consent

Where it is running

• London Health Sciences Centre Research Institute — London, Ontario, Canada (enrolling)
• University of Arizona — Tucson, Arizona, United States (enrolling)
• Jennifer Moreno Department of Veterans Affairs Medical Cneter — San Diego, California, United States (enrolling)
• Kaiser Permanente Northern California — Walnut Creek, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• MedStar Health — Washington D.C., District of Columbia, United States (enrolling)
• James A. Haley Veterans Hospital — Tampa, Florida, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• Richard L. Roudebush VA Medical Center — Indianapolis, Indiana, United States (enrolling)
• University of Michigan Health — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford — Detroit, Michigan, United States (enrolling)
• Dartmouth Health — Lebanon, New Hampshire, United States (enrolling)
• New York Harbor Health Care System - Dept of Veterans Affairs — New York, New York, United States (enrolling)
• University of British Columbia — Vancouver, British Columbia, Canada (enrolling)
• University of Manitoba — Winnipeg, Manitoba, Canada (enrolling)
• Oregon Health & Science University (Knight Cancer Institute) — Portland, Oregon, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Intermountain Health — Sandy City, Utah, United States (enrolling)
• University of Virginia Health — Charlottesville, Virginia, United States (enrolling)
• University of Calgary — Calgary, Alberta, Canada (enrolling)
• Kaiser Permanente Northwest — Portand, Oregon, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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