Quantitation of faecal Fusobacterium improves faecal immunochemical test in detecting advanced colorectal neoplasia.
Sunny H Wong, Thomas N Y Kwong, Tai-Cheong Chow...
https://pubmed.ncbi.nlm.nih.gov/27797940/Actively Recruiting
Led by Chinese University of Hong Kong · Updated on 2024-08-27
600
Participants Needed
1
Research Sites
26 weeks
Total Duration
Colorectal cancer is a common cancer with increasing cases among younger people worldwide. Early detection and removal of colonic adenomas can reduce deaths related to colorectal cancer. Researchers are investigating the accuracy of a new panel of four bacterial gene markers, called M3, and the faecal immunochemical test FIT to detect advanced adenomas that return in patients who previously had colonic adenomas. The study compares the diagnostic accuracy of FIT and M3, which includes markers Fn, m3, Ch, and Bc, by analyzing stool samples. Participants have a history of colorectal adenomas identified during their previous colonoscopy. This observational study follows patients over three years to assess how well these tests detect recurrent advanced adenomas. Participants will undergo surveillance colonoscopies and provide stool samples for testing with FIT and the M3 panel. Researchers will measure the sensitivity and specificity of these tests in detecting advanced, non-advanced, and all adenomas at year three. The study monitors participants for three years to evaluate these diagnostic tools performance in identifying adenoma recurrence.
CONDITIONS
Diagnostic Accuracy of M3 in Predicting Colorectal Advanced Adenoma Recurrence (M3-AA)
M
Min Dai
C
Connie Seto
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Chinese University of Hong Kong
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 years
Participants provide stool samples for testing using the M3 panel and the faecal immunochemical test (FIT) to detect recurrent advanced adenomas.
Regular stool sample collections as per surveillance schedule
Duration - Up to 3 years
Participants undergo surveillance colonoscopy at regular intervals depending on their clinical findings to monitor for colorectal adenoma recurrence.
Surveillance colonoscopy visits as scheduled by clinical care
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Lead Sponsor