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Colonoscopy Surveillance for Non-Advanced Adenomatous Polyps

This study is looking at how often people with 1-2 non-advanced adenomatous polyps (growths in the colon that are not yet cancer) need a colonoscopy. It compares two groups: one group will have a colonoscopy after 10 years, and the other group will have colonoscopies after 5 and 10 years. The main goal is to see how many people in each group develop colorectal cancer over 10 years. You may be able to join if you are between 45 and 70 years old and have recently been diagnosed with 1-2 non-advanced tubular adenomas. The current status of this study is unclear.

Study design
This interventional study plans to enroll 9500 participants to compare two different schedules for surveillance colonoscopies.
What's involved
Participants will undergo colonoscopies at either 5 and 10 years, or at 10 years, following standard preparation instructions.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for the incidence of colorectal cancer for 10 years.

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NCT05080673

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

Recruiting
NAAges 45–70Interventional
NRG Oncology
~9,500 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

At a glance

Recruiting sites
343 of 493 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of colorectal cancer
Measured over 10 years

Conditions

Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum

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NCT05080673

Where you'd take part

This study runs at 493 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraskastudy coordinator listed

    Recruiting

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraskastudy coordinator listed

    Recruiting

  • Alegent Health Lakeside Hospital

    Omaha, Nebraskastudy coordinator listed

    Recruiting

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevadastudy coordinator listed

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohiostudy coordinator listed

    Recruiting

  • Audie L Murphy VA Hospital

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Robert Schoen, MD · STUDY_CHAIR · University of Pittsburgh

Who to contact

Director, Department of Regulatory Affairs
[email protected]
412-339-5300
Email the study team

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Eligibility criteria

Inclusion

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

• 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.

What this trial measures

  • Incidence of colorectal cancer10 years

    To examine 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.