NCT05080673 Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
| NCT ID | NCT05080673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NRG Oncology |
| Condition | Adenocarcinoma of the Colon |
| Study Type | INTERVENTIONAL |
| Enrollment | 9,500 participants |
| Start Date | 2022-02-09 |
| Primary Completion | 2035-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9,500 participants in total. It began in 2022-02-09 with a primary completion date of 2035-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines. * Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy. * 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 less 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.
Contact & Investigator
Robert Schoen, MD
STUDY CHAIR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05080673 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 70 Years, studying Adenocarcinoma of the Colon. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05080673 currently recruiting?
Yes, NCT05080673 is actively recruiting participants. Contact the research team at langerj@nrgoncology.org for enrollment information.
Where is the NCT05080673 trial being conducted?
This trial is being conducted at Fairbanks, United States, Goodyear, United States, Kingman, United States, Phoenix, United States and 11 additional locations.
Who is sponsoring the NCT05080673 clinical trial?
NCT05080673 is sponsored by NRG Oncology. The principal investigator is Robert Schoen, MD at University of Pittsburgh. The trial plans to enroll 9,500 participants.