Comparing colonoscopy and stool testing for older adults with colon polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-site randomized controlled trial compares the effectiveness of annual fecal immunochemical testing (FIT) versus colonoscopy for surveillance in adults aged 65-82 with a history of colorectal polyps. The study aims to address the challenges and risks associated with repeated colonoscopies in older adults, particularly those with low-risk polyps. By evaluating the noninvasive FIT as a potential alternative, the trial seeks to determine if it can provide similar benefits while reducing the risks associated with invasive procedures. Participants will be monitored for outcomes related to colorectal cancer prevention and overall health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• Jennifer Moreno Department of Veterans Affairs Medical Cneter
  San Diego, California, United States Recruiting
• Kaiser Permanente Northern California
  Walnut Creek, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting
• MedStar Health
  Washington D.C., District of Columbia, United States Recruiting
• James A. Haley Veterans Hospital
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Audrey H Calderwood, MD, MS — Dartmouth-Hitchcock Medical Center
• Study coordinator: Barbie Patel, MPH
• Email: coopstudy@hitchcock.org
• Phone: 857-4987233

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.