Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Launched by NRG ONCOLOGY · Oct 4, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how often people who have had 1 or 2 non-advanced adenomas (small growths that can develop in the colon) should have follow-up colonoscopies to check for colorectal cancer. Participants in the trial will be randomly assigned to either have a colonoscopy every 5 years or every 10 years to see which schedule is more effective at preventing cancer.
To be eligible for this study, participants need to have recently been diagnosed with 1-2 non-advanced adenomas during a complete colonoscopy, which is a procedure that allows doctors to look inside the colon. People who have a history of certain types of polyps or colorectal cancer, as well as those with specific medical conditions, are not eligible. Participants can expect to contribute to important research while receiving regular check-ups for their health. This study is currently recruiting and is open to people aged 18 and older, regardless of gender.
Gender
ALL
Eligibility criteria
- 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.
About Nrg Oncology
NRG Oncology is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative multi-institutional studies. Comprising a collaborative network of leading academic institutions and community hospitals, NRG Oncology focuses on enhancing patient outcomes by conducting rigorous clinical trials that evaluate new treatment strategies and improve existing therapies. With a commitment to scientific excellence and patient-centered care, the organization plays a vital role in shaping the future of oncology by integrating cutting-edge research with clinical practice, ultimately striving to translate findings into meaningful improvements in cancer care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Saint Joseph, Michigan, United States
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Dayton, Ohio, United States
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Patients applied
Trial Officials
Robert Schoen, MD
Study Chair
University of Pittsburgh
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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