NRG-CC005: FORTE (5- or 10-Year Colonoscopy for 1 – 2 Non-Advanced Adenomatous Polyps)
About
This trial examines colorectal cancer incidence in participants with 1 – 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.
Eligibility Criteria
Inclusion Criteria
- Participants ≥ 50 and < 70 years of age at the time of randomization.
- Participants with a first-time diagnosis of 1 – 2 non-advanced tubular adenomas (< 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization.
- Complete excision of all observed polyps in qualifying colonoscopy.
Exclusion Criteria
- Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those 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.
- Known family history of CRC diagnosed at ≤ 60 years of age in a first degree relative (mother, father, child, sibling) or in 2 first degree relatives with CRC at any age.
- Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis).
Primary Investigator
Dr. Terry Paul Nickerson is a board-certified colon and rectal surgeon. He completed his General Surgery residency and Colon and Rectal Surgery fellowship at the Mayo Clinic in Rochester, Minnesota. After finishing his fellowship, Dr. Nickerson worked at MD Anderson Cancer Center, an NCI-designated Comprehensive Cancer Center in Houston, TX. In 2019, he joined the Department of General Surgery at Carilion Clinic as a colon and rectal Surgeon. Dr. Nickerson is also an associate professor at the Virginia Tech Carilion School of Medicine.
Contact Information
Bailey Steele, MPH
Clinical Research Coordinator
