RecruitingAdenocarcinoma of the ColonAdenocarcinoma of the Rectum

Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

Eligible age

45–70 yrs

Accepts

All genders

Locations

46 states

Healthy volunteers

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About this study

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.

Sponsor: NRG Oncology

You may qualify if…

✓ 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.

You may not qualify if…

✕ • 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 is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin.
✕ Colonoscopy performed after the qualifying colonoscopy but prior to randomization.
✕ Incomplete qualifying colonoscopy (e.g., cecum not visualized).
✕ Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.)