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

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Trial ID: NCT05080673

Purpose

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.

Official Title

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

Stanford Investigator(s)

Uri Ladabaum
Uri Ladabaum

Professor of Medicine (Gastroenterology and Hepatology)

Eligibility


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.

Intervention(s):

procedure: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michelle Narayan
650-725-2732

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