RecruitingNot ApplicableNCT05612347
Colonoscopy vs Stool Testing for Older Adults With Colon Polyps
Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
8,946 participants
Start Date
Jun 14, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 65 YearsMax Age: 82 Years
Inclusion Criteria5
- 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 Criteria6
- 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
Interventions
DIAGNOSTIC_TESTFIT
Annual FIT
DIAGNOSTIC_TESTColonoscopy
One time surveillance colonoscopy
Locations(19)
View Full Details on ClinicalTrials.gov
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NCT05612347
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