Evaluating a new test for predicting colorectal adenoma recurrence
A Prospective Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) in Predicting Colorectal Advanced Adenoma Recurrence
This study is testing a new test that looks at specific bacteria in the stool to see if it can better predict the return of advanced polyps in people who have had colon polyps before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT05144152 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a known history of colorectal adenomas.
Not a fit: Patients with a personal history of colorectal cancer, polyposis syndrome, or inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of recurrent advanced adenomas, potentially reducing colorectal cancer mortality.
How similar studies have performed: Other studies have shown promise in using bacterial gene markers for colorectal cancer detection, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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);
Where this trial is running
Shatin, New Territories
- Prince of Wales Hospital — Shatin, New Territories, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Min Dai
- Email: mindai@link.cuhk.edu.hk
- Phone: +85260490760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.