Diagnostic Accuracy of M3 in Predicting Colorectal Advanced Adenoma Recurrence (M3-AA)

Launched by CHINESE UNIVERSITY OF HONG KONG · Nov 21, 2021

Keywords

ClinConnect Summary

This clinical trial, called M3-AA, is studying a new method to help doctors predict the recurrence of advanced colorectal adenomas, which are growths in the colon that can potentially lead to cancer. The researchers are comparing a common test called FIT (which checks for blood in the stool) with a new test that looks for specific bacterial gene markers, known as M3. They want to see which test is more accurate in detecting these growths in patients who have a history of colorectal adenomas.

To participate in this trial, you need to be at least 18 years old and have had colorectal adenomas identified during a previous colonoscopy. You should also have test results for both M3 and FIT available from before your last colonoscopy. Participants will undergo surveillance colonoscopy, a procedure where doctors look inside the colon, to check for any new or recurring adenomas. It's important to note that individuals with certain health conditions or previous surgeries may not be eligible for this study. Overall, this trial aims to improve how we monitor patients at risk for colorectal cancer by using new diagnostic tools.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Known colorectal adenomas during index colonoscopy;
• • 2. Available baseline M3 and FIT results before index colonoscopy;
• • 3. Aged ≥18 years old;
• • 4. Written informed consent obtained.
• Exclusion Criteria:
• • 1. Refusal or unfit to undergo surveillance colonoscopy;
• • 2. Incomplete colonoscopy, incomplete removal of colorectal adenomas, or inadequate bowel preparation (defined as Boston Bowel Preparation Scale score 0 or 1 in any colonic segment) at index colonoscopy;
• • 3. Previous colonic resection;
• • 4. Personal history of colorectal cancer;
• • 5. Personal history of polyposis syndrome;
• • 6. Personal history of inflammatory bowel disease;
• • 7. Known pregnancy or lactation;
• • 8. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);