Status:
RECRUITING
Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Dr Cipto Mangunkusumo General Hospital
Aster CMI Hospital
Conditions:
Colorectal Cancer
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
The investigators aim to evaluate and compare the diagnostic accuracy of FIT and the novel panel of bacterial gene markers (Fn, m3, Ch and Bc) collectively named as M3, in detecting colorectal advance...
Detailed Description
Colorectal cancer (CRC) is the one of the most common cancers in Hong Kong with more than 5,500 new cases annually. There is prevailing evidence of increasing trend of young onset CRC globally. Early ...
Eligibility Criteria
Inclusion
- They require elective colonoscopy for colorectal cancer screening or polyp surveillance, or investigation of symptoms (e.g. anemia, change of bowel habit, abdominal pain);
- Aged ≥18 years old;
- Written informed consent obtained.
Exclusion
- Contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status);
- Contraindication to polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets);
- Known colorectal cancer or adenoma for staged procedure;
- 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);
Key Trial Info
Start Date :
June 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT05405673
Start Date
June 29 2022
End Date
December 31 2025
Last Update
August 27 2024
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, Hong Kong