Actively Recruiting
A Prospective Multi-center Study to Assess Diagnostic Accuracy of Bacterial Gene Markers Panel (M3) for Colorectal Advanced Neoplasia
Led by Chinese University of Hong Kong · Updated on 2024-08-27
2500
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
D
Dr Cipto Mangunkusumo General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating and comparing the accuracy of a stool test called the fecal immunochemical test (FIT) with a new panel of bacterial gene markers known as M3 for detecting advanced colorectal neoplasia. This study focuses on colorectal cancer, a common cancer with rising cases in younger people, aiming to improve early detection of pre-cancerous growths to reduce mortality. The study involves collecting stool samples from participants who need colonoscopy for screening or symptom investigation. The M3 panel includes four bacterial gene markers (Fn, m3, Ch, and Bc) shown in earlier studies to have higher sensitivity than FIT for detecting adenomas and colorectal cancer. Participants undergo diagnostic stool tests using FIT and the M3 panel before their colonoscopy. Participants will be evaluated for the sensitivity and specificity of these tests to detect colorectal advanced neoplasia within one month. The study measures include sensitivity for early and invasive colorectal cancer stages, adenomas, sessile serrated lesions, and overall diagnostic accuracy. Microbiota changes after polyp removal will also be assessed. The total study duration is based on the timeframe around colonoscopy and sample analysis.
CONDITIONS
Brief Title
Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must need a colonoscopy for colorectal cancer screening, polyp follow-up, or symptoms like anemia, bowel habit change, or abdominal pain
- Aged 18 years or older
- Able to provide written informed consent
You will not qualify if you...
- Cannot safely undergo colonoscopy (e.g., bowel perforation, obstruction, unstable heart or lung condition)
- Cannot safely have polyp removal (e.g., active GI bleeding, ongoing anticoagulant or dual antiplatelet therapy)
- Known colorectal cancer or adenoma planned for staged procedure
- Previous colon surgery
- Personal history of colorectal cancer
- Personal history of polyposis syndrome
- Personal history of inflammatory bowel disease
- Currently pregnant or breastfeeding
- Severe other health conditions classified as ASA grade 4 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants provide stool samples to undergo diagnostic testing including the fecal immunochemical test (FIT) and bacterial gene markers panel (M3) to assess for colorectal advanced neoplasia.
1 visit (stool sample collection)
Duration - Up to 1 month
Participants with average risk requiring screening or surveillance colonoscopy are observed to monitor microbiota changes and outcomes after polypectomy if applicable.
Follow-up assessments depending on clinical findings
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
C
Connie Seto
M
Min Dai
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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