RecruitingNCT05405673

Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced 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

Sponsor

Chinese University of Hong Kong

Enrollment

2,500 participants

Start Date

Jun 29, 2022

Study Type

OBSERVATIONAL

Conditions

Colorectal, Cancer Colorectal Neoplasms Colorectal Adenoma

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 advanced neoplasia.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria9

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);