Comparing colonoscopy and stool testing for older adults with colon polyps
Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps
This study is testing whether a simple stool test can be just as effective as colonoscopy for monitoring older adults with a history of colon polyps.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8946 (estimated) |
| Ages | 65 Years to 82 Years |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 22 sites (Birmingham, Alabama and 21 other locations) |
| Trial ID | NCT05612347 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English or Spanish speaking adults aged 65-82 with a personal history of colorectal polyps and due for surveillance colonoscopy.
Not a fit: Patients with a history of colorectal cancer, advanced polyps, or significant comorbidities that limit their ability to benefit from polyp surveillance may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more convenient surveillance option for older adults at risk of colorectal cancer.
How similar studies have performed: While similar studies have shown FIT to be effective in other populations, this specific approach for older adults with low-risk adenomas is novel and has not been extensively tested in the US.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Birmingham, Alabama and 21 other locations
- University of Alabama Birmingham — Birmingham, Alabama, United States (Active_not_recruiting)
- 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)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- Richard L. Roudebush VA Medical Center — Indianapolis, Indiana, United States (Recruiting)
- University of Michigan Health — Ann Arbor, Michigan, United States (Recruiting)
- Henry Ford — Detroit, Michigan, United States (Recruiting)
- Dartmouth Health — Lebanon, New Hampshire, United States (Recruiting)
- New York Harbor Health Care System - Dept of Veterans Affairs — New York, New York, United States (Recruiting)
- Kaiser Permanente Northwest — Portand, Oregon, United States (Active_not_recruiting)
- Oregon Health & Science University (Knight Cancer Institute) — Portland, Oregon, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Intermountain Health — Sandy City, Utah, United States (Recruiting)
- University of Virginia Health — Charlottesville, Virginia, United States (Recruiting)
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
- University of Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
- London Health Sciences Centre Research Institute — London, Ontario, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.