Comparing Annual Stool Testing and Colonoscopy for Adults Aged 65 to 82 With a History of Colon Polyps

What this Trial Is About

Researchers are evaluating the effectiveness of two surveillance methods for older adults aged 65 to 82 who have a history of colorectal polyps. The study compares annual fecal immunochemical testing FIT, a noninvasive stool-based test, with colonoscopy, the usual follow-up procedure, to understand which approach better detects colorectal cancer in this population. This trial addresses the need for alternative surveillance options that may reduce risks and discomfort associated with repeated colonoscopies in older adults who often have low-risk polyps. Participants are randomly assigned to one of two groups one receives annual at-home FIT, while the other undergoes a one-time surveillance colonoscopy. FIT is widely used for colorectal cancer screening in average-risk adults and is already a standard surveillance option in some countries. The study will observe these methods over several years to compare their effectiveness and participant experiences. Throughout the study, participants will provide stool samples annually if assigned to the FIT group or undergo colonoscopy once if in the colonoscopy group. Researchers will monitor the detection of advanced neoplasia over up to 11 years. Additional assessments include surveys measuring satisfaction, worry about colorectal cancer, perceived cancer risk, emotional impact, and overall health. Safety monitoring for colonoscopy-related harms will occur within 30 to 45 days after the procedure. The total study duration extends through 2035, with primary outcome assessment planned by 2030.

Colonoscopy vs Stool Testing for Older Adults With Colon Polyps