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Colonoscopy versus Stool-Based Testing for Colorectal Cancer Screening in Older Patients with a History of Colon Polyps, The COOP Trial
Trial Status: active
This clinical trial compares how well a colonoscopy works versus at-home stool-based testing (fecal immunochemical test [FIT]) in screening for and detecting colorectal cancer in patients age 70-82 who have a history of colon polyps. A polyp is a growth on the lining of the colon wall. Colorectal cancer usually starts in a polyp. Therefore, adults aged 45 or older who have had colorectal polyps are considered to be at higher risk for colorectal cancer. Because of this increased risk, these patients are referred for colonoscopies more often than patients who did not have polyps to look for additional polyps. These follow-up colonoscopies are called “surveillance colonoscopy”. However, patients who may benefit from this surveillance may not want to have a colonoscopy due to the risks, burdens and inconveniences of the procedure and preparation. FIT is a non-invasive, convenient, low cost, stool-based screening test for colorectal cancer. FIT looks for hidden blood in the stool, which can be an early sign of colorectal cancer. It has the advantage of being done at home without any risks, sedation or need for a change in diet and bowel preparation, but it cannot identify and remove polyps like colonoscopy. By comparing FIT to surveillance colonoscopy in this study, the researchers hope to learn more about patients’ preferences for surveillance and how well FIT works compared to colonoscopy for surveillance in people who’ve had polyps.
Inclusion Criteria
English or Spanish speaking people 70-82 years of age at the time of enrollment
Personal history of colorectal polyps (>= 1 lifetime adenoma, sessile serrated polyp, clinically significant hyperplastic polyp defined as size >= 1 cm or > 5 mm in the proximal colon [defined as proximal to the splenic flexure])
Most recent colonoscopy with =< 2 non-advanced adenomas (defined as adenomas < 1 cm in size and without villous features or high grade dysplasia) or non-advanced serrated polyps
Currently due or coming due within 12 months for colonoscopy for a primary indication of surveillance due to polyp history
Able to provide written informed consent
Exclusion Criteria
Personal history of colorectal cancer (CRC)
Personal history of a genetic syndrome with high risk for CRC (e.g., Lynch syndrome, Familial Adenomatous Polyposis Syndrome, Serrated Polyposis Syndrome)
Personal history of inflammatory bowel disease
Most recent colonoscopy with advanced adenoma(s) (adenoma >= 1cm or with villous histology or high grade dysplasia) or advanced serrated polyps (serrated polyps >= 1cm or with dysplasia or traditional serrated polyp)
Most recent colonoscopy with >= 3 non-advanced adenomas or non-advanced serrated polyps
Patients with an existing, scheduled appointment for surveillance colonoscopy
Patients unlikely to benefit from surveillance (e.g., poor overall health, advanced dementia, or high risk for colonoscopy)
Patients unable to provide informed consent
Lack of valid mailing address
Additional locations may be listed on ClinicalTrials.gov for NCT05612347.
I. To compare annual FIT (using the Food and Drug Administration [FDA] cleared threshold of >= 20 ug hemoglobin [Hgb]/g defining a positive test) versus colonoscopy for surveillance in adults age 70-82 with a history of low-risk polyps who are due or coming due for surveillance colonoscopy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a FIT kit and complete FIT at home annually on study.
ARM II: Patients undergo one-time surveillance colonoscopy on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
