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

NCT05144152 | Recruiting DMC

• 1 other identifier: 2021.558
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to evaluate the diagnostic accuracy of FIT and the novel panel of four bacterial gene markers collectively named as M3, to detect recurrent advanced adenomas in patients with history of colonic adenomas.

Conditions

Colorectal Adenoma; Advanced Adenoma; Colorectal Polyp

Keywords

FIT; Bacterial marker; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the panel of bacterial gene markers (M3) or FIT in detection of recurrent colonic advanced adenomas

  The proportion of subjects with true positive results of either M3 or FIT among those with one of more advanced adenomas detected during the surveillance colonoscopy examination at year 3

  3 years

Secondary Outcomes (4)

• Sensitivity for advanced adenomas (year 3)

  3 years

• Sensitivity for non-advanced adenomas (year 3)

  3 years

• Sensitivity for all adenomas (year 3)

  3 years

• Specificity (year 3)

  3 years

Study Arms (1)

History of colorectal adenomas group

Subjects with known colorectal adenomas at the index colonoscopy

Diagnostic Test: M3; Diagnostic Test: FIT

Interventions

M3 DIAGNOSTIC_TEST

A panel of four bacterial gene markers (Fn, m3, Ch and Bc)

History of colorectal adenomas group

FIT DIAGNOSTIC_TEST

faecal immunochemical test

History of colorectal adenomas group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subeject with history of colorectal adenomas

You may qualify if:

• Known colorectal adenomas during index colonoscopy;
• Available baseline M3 and FIT results before index colonoscopy;
• Aged ≥18 years old;
• Written informed consent obtained.

You may not qualify if:

• Refusal or unfit to undergo surveillance colonoscopy;
• Incomplete colonoscopy, incomplete removal of colorectal adenomas, or inadequate bowel preparation (defined as Boston Bowel Preparation Scale score 0 or 1 in any colonic segment) 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);

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

Related Publications (12)

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Biospecimen

Retention: SAMPLES WITH DNA

Stool sample

Central Study Contacts

Min Dai

CONTACT

+85260490760; mindai@link.cuhk.edu.hk

Connie Seto

CONTACT

+85260490760; waiyiseto@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Specialist

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 3, 2021
• Study Start: December 13, 2021
• Primary Completion: December 15, 2024
• Study Completion: June 15, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)