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Comparing 5-year and 10-year colonoscopy schedules for patients with non-advanced adenomas

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

Not applicable Interventional NRG Oncology · NCT05080673

This study is testing whether people with 1 to 2 non-advanced polyps can safely have colonoscopies every 10 years instead of every 5 years without raising their risk of colorectal cancer.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment9500 (estimated)
Ages45 Years to 70 Years
SexAll
SponsorNRG Oncology Academic / other
Locations486 sites (Fairbanks, Alaska and 485 other locations)
Trial IDNCT05080673 on ClinicalTrials.gov

What this trial studies

This trial investigates the incidence of colorectal cancer in participants with 1 to 2 non-advanced adenomatous polyps by comparing surveillance colonoscopy intervals of 5 years versus 10 years. Participants will be randomized to either group following a qualifying colonoscopy that identifies their adenomas. The study aims to determine if extending the surveillance interval can safely reduce the frequency of colonoscopies without increasing cancer risk. The trial is significant given the high prevalence of colorectal cancer and the importance of effective screening strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 and older who have been diagnosed with 1-2 non-advanced tubular adenomas.

Not a fit: Patients with a history of colorectal cancer or advanced adenomas will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and potentially less frequent colonoscopy schedules for patients with non-advanced adenomas, reducing healthcare costs and patient burden.

How similar studies have performed: Other studies have shown success in screening strategies for colorectal cancer, but this specific approach of comparing surveillance intervals for non-advanced adenomas is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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 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 this trial is running

Fairbanks, Alaska and 485 other locations

+436 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.