Evaluating a new test for predicting colorectal adenoma recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the diagnostic accuracy of a novel panel of bacterial gene markers, referred to as M3, alongside the faecal immunochemical test (FIT) for detecting recurrent advanced adenomas in patients with a history of colonic adenomas. Given the limitations of FIT in identifying advanced adenomas, this observational study seeks to provide a more sensitive non-invasive alternative for early detection. Participants will undergo surveillance colonoscopy at regular intervals based on their adenoma history, and the effectiveness of M3 in conjunction with FIT will be evaluated. The study is particularly relevant in light of the rising incidence of colorectal cancer, especially among younger populations.

Why it matters

Who can join: the full rules

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);

Where it's running

• Prince of Wales Hospital
  Shatin, New Territories, Hong Kong Recruiting

Study contacts

• Study coordinator: Min Dai
• Email: mindai@link.cuhk.edu.hk
• Phone: +85260490760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.