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

Recruiting now · Not applicable

Conditions studied: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum

In brief

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.

Key facts

Study ID

NCT05080673

Run by

NRG Oncology

People needed

9500

Starts

2022-02-09

Expected to finish

2065-11-01

Last updated by the study team

2026-08-04

Who can join

Age: 45 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.)
• Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.)
• Family history of CRC diagnosed at less than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age.
• Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer [Lynch Syndrome]).
• Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer [Lynch Syndrome] genetic mutation that increases risk of colorectal cancer.
• Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis).
• Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator.
• Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.

Where it is running

• Kaiser Permanente-Ontario — Ontario, California, United States (enrolling)
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States (enrolling)
• Mercy Cancer Center — Merced, California, United States (enrolling)
• University of Arizona Cancer Center - Prevention Research Clinic — Tucson, Arizona, United States (enrolling)
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (enrolling)
• Kingman Regional Medical Center — Kingman, Arizona, United States (enrolling)
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (enrolling)
• Contra Costa Regional Medical Center — Martinez, California, United States (enrolling)
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States (enrolling)
• PCR Oncology — Arroyo Grande, California, United States (enrolling)
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States (enrolling)
• Kaiser Permanente-Bellflower — Bellflower, California, United States (enrolling)
• Mercy Cancer Center - Carmichael — Carmichael, California, United States (enrolling)
• Mercy San Juan Medical Center — Carmichael, California, United States (enrolling)
• CARTI Cancer Center — Little Rock, Arkansas, United States (enrolling)
• Mercy Cancer Center - Elk Grove — Elk Grove, California, United States (enrolling)
• Kaiser Permanente-Anaheim — Anaheim, California, United States (enrolling)
• CTCA at Western Regional Medical Center — Goodyear, Arizona, United States (enrolling)
• Kaiser Permanente-Fontana — Fontana, California, United States (enrolling)
• Kaiser Permanente South Bay — Harbor City, California, United States (enrolling)
• Kaiser Permanente-Irvine — Irvine, California, United States (enrolling)
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Kaiser Permanente West Los Angeles — Los Angeles, California, United States (enrolling)
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Kaiser Permanente - Panorama City — Panorama City, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.