Actively Recruiting

Age: 18Years +
All Genders
ID05144152

A Prospective Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) in Predicting Colorectal Advanced Adenoma Recurrence

Led by Chinese University of Hong Kong · Updated on 2024-08-27

600

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Diagnostic Accuracy of M3 in Predicting Colorectal Advanced Adenoma Recurrence (M3-AA)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Known colorectal adenomas during index colonoscopy
  • Available baseline M3 and FIT results before index colonoscopy
  • Aged 18 years or older
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Refusal or unfitness to undergo surveillance colonoscopy
  • Incomplete colonoscopy, incomplete removal of colorectal adenomas, or inadequate bowel preparation at index colonoscopy
  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Surveillance

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

Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

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Research Team

M

Min Dai

C

Connie Seto

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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Published Research Related To This Trial

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

Fusobacterium and colorectal cancer: causal factor or passenger? Results from a large colorectal cancer screening study.

Efrat L Amitay, Simone Werner, Marius Vital...

https://pubmed.ncbi.nlm.nih.gov/28582482

Prevalence of adenomas and colorectal cancer in average risk individuals: a systematic review and meta-analysis.

Steven J Heitman, Paul E Ronksley, Robert J Hilsden...

https://pubmed.ncbi.nlm.nih.gov/19523536

Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer.

Douglas J Robertson, Jeffrey K Lee, C Richard Boland...

https://pubmed.ncbi.nlm.nih.gov/27769517