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A Study to Examine How Often (Every 5 Years or 10 Years) a Colonoscopy Should be Done in Participants Who Had One or Two Small Growths of Tissue Removed from Their Colon


Active: Yes
Cancer Type: Colon/Rectal Cancer NCT ID: NCT05080673
Trial Phases: Phase III Protocol IDs: NRG-CC005 (primary)
NRG-CC005
NRG-CC005
NCI-2020-00733
Eligibility: 50 - 70 Years, Male and Female Study Type: Health services research
Study Sponsor: NRG Oncology
NCI Full Details: http://clinicaltrials.gov/show/NCT05080673

Summary

This phase III trial compares how often (every 5 and 10 years versus every 10 years) a colonoscopy should be done in participants who had one or two non-cancerous (benign) small growth of tissue (polyps) removed from their colon. The usual approach is to have a repeat colonoscopy in 5 to 10 years. The goal of this study is to find the best timing for a repeat colonoscopy for patients with 1 or 2 small benign polyps removed during colonoscopy.

Objectives

PRIMARY OBJECTIVE:
I. 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.

PRE-DEFINED EXPLORATORY OBJECTIVES:
I. To examine advanced adenoma 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.
II. To examine colorectal cancer mortality 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.
III. To examine stage III-IV 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.

EXPLORATORY OBJECTIVE:
I. Collection of blood, stool, and tissue samples for purposes of the NRG-CC005 study and for future unspecified research.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo repeat colonoscopy at 5 and 10 years after benign polyp removal.

ARM 2: Patients undergo repeat colonoscopy at 10 years after benign polyp removal.

Patients have the option to be followed for up to 30 years after joining the study.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.