Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps (NCT05080673) | Clinical Trial Compass
RecruitingNot Applicable
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
United States9,500 participantsStarted 2022-02-09
Plain-language 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.
Who can participate
Age range45 Years – 70 Years
SexALL
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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 colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy.
* Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size.
* Traditional serrated adenomas found on the qualifying colonoscopy.
* Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy.
* Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and i…