NCT05080673 Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
| NCT ID | NCT05080673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NRG Oncology |
| Condition | Adenocarcinoma of the Colon |
| Study Type | INTERVENTIONAL |
| Enrollment | 9,500 participants |
| Start Date | 2022-02-09 |
| Primary Completion | 2035-11-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.
Eligibility Criteria
Inclusion Criteria: * The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines. * Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy. * Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization. * Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas. * Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization. * Complete excision of all observed polyps in qualifying colonoscopy * Participants must be able to read or understand English or Spanish. Exclusion Criteria: * • Prior history of colorectal cancer or color