Evaluating a new test for detecting advanced colorectal neoplasia
A Prospective Cross-sectional Multi-center Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
This study is testing a new test using bacterial gene markers to see if it can better detect advanced colorectal issues compared to the standard stool test for people needing a colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05405673 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the diagnostic accuracy of a new panel of bacterial gene markers, referred to as M3, in comparison to the traditional fecal immunochemical test (FIT) for detecting advanced colorectal neoplasia. Colorectal cancer is a significant health concern, particularly in Hong Kong, where early detection is crucial for reducing mortality rates. The study will involve patients who require elective colonoscopy for screening or symptom investigation, and it will analyze the effectiveness of the M3 markers in identifying colorectal adenomas and cancer. By improving detection rates, this research seeks to enhance non-invasive screening methods for colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require elective colonoscopy for colorectal cancer screening or related symptoms.
Not a fit: Patients with known colorectal cancer, previous colonic resection, or severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate non-invasive screening methods for colorectal cancer, potentially saving lives through earlier detection.
How similar studies have performed: While some studies have explored bacterial gene markers for colorectal cancer detection, this specific approach using the M3 panel is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. They require elective colonoscopy for colorectal cancer screening or polyp surveillance, or investigation of symptoms (e.g. anemia, change of bowel habit, abdominal pain); 2. Aged ≥18 years old; 3. Written informed consent obtained. Exclusion Criteria: 1. Contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status); 2. Contraindication to polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets); 3. Known colorectal cancer or adenoma for staged procedure; 4. Previous colonic resection; 5. Personal history of colorectal cancer; 6. Personal history of polyposis syndrome; 7. Personal history of inflammatory bowel disease; 8. Known pregnancy or lactation; 9. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Connie Seto
- Email: waiyiseto@cuhk.edu.hk
- Phone: 6049 0760
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.