Open Actively Recruiting

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

About

Brief Summary

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.

Primary Purpose
Other
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
50 Years
Maximum Age
70 Years

Inclusion Criteria:

    • The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
      • 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 less 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 greater 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.

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Study Stats
Protocol No.
21-001972
Category
Gastroenterology
Oncology
Principal Investigator
Folasade May
Contact
Barbara Kahn-Mills
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05080673
For detailed technical eligibility, visit ClinicalTrials.gov.