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

Overview

About this study

The purpsoe of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/13/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lisa Boardman, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available