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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CTCA at Western Regional Medical Center
  Goodyear, Arizona, United States Recruiting
• Kingman Regional Medical Center
  Kingman, Arizona, United States Recruiting
• Cancer Center at Saint Joseph's
  Phoenix, Arizona, United States Recruiting
• University of Arizona Cancer Center - Prevention Research Clinic
  Tucson, Arizona, United States Recruiting
• Mercy Hospital Fort Smith
  Fort Smith, Arkansas, United States Recruiting
• CARTI Cancer Center
  Little Rock, Arkansas, United States Recruiting

+449 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Director, Department of Regulatory Affairs
• Email: langerj@nrgoncology.org
• Phone: 412-339-5300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.