RecruitingNCT05144152
Diagnostic Accuracy of M3 in Predicting Colorectal Advanced Adenoma Recurrence (M3-AA)
A Prospective Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) in Predicting Colorectal Advanced Adenoma Recurrence
Sponsor
Chinese University of Hong Kong
Enrollment
600 participants
Start Date
Dec 13, 2021
Study Type
OBSERVATIONAL
Conditions
Summary
The investigators aim to evaluate the diagnostic accuracy of FIT and the novel panel of four bacterial gene markers collectively named as M3, to detect recurrent advanced adenomas in patients with history of colonic adenomas.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Known colorectal adenomas during index colonoscopy;
- Available baseline M3 and FIT results before index colonoscopy;
- Aged ≥18 years old;
- Written informed consent obtained.
Exclusion Criteria8
- Refusal or unfit to undergo surveillance colonoscopy;
- 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;
- Previous colonic resection;
- Personal history of colorectal cancer;
- Personal history of polyposis syndrome;
- Personal history of inflammatory bowel disease;
- Known pregnancy or lactation;
- Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
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Interventions
DIAGNOSTIC_TESTM3
A panel of four bacterial gene markers (Fn, m3, Ch and Bc)
DIAGNOSTIC_TESTFIT
faecal immunochemical test
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05144152
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