Health TrialsbyHealthPanel

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

ConditionsColorectal AdenomaAdvanced AdenomaColorectal Polyp
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Known colorectal adenomas during index colonoscopy;

Available baseline M3 and FIT results before index colonoscopy;

Aged ≥18 years old;

Written informed consent obtained.

Disqualifiers

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;

Trial population

Subeject with history of colorectal adenomas

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • M3

    Diagnostic test

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

  • FIT

    Diagnostic test

    faecal immunochemical test

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: History of colorectal adenomas group2 interventions

Trial outcomes

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

Time frame
3 years

Secondary outcomes

1

Sensitivity for advanced adenomas (year 3)

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

Time frame
3 years
2

Sensitivity for non-advanced adenomas (year 3)

The proportion of subjects with true positive results of either M3 or FIT among those with non-advanced adenomas detected at year 3 colonoscopy

Time frame
3 years
3

Sensitivity for all adenomas (year 3)

The proportion of subjects with true positive results of either M3 or FIT among those with all adenomas detected at year 3 colonoscopy

Time frame
3 years
4

Specificity (year 3)

Proportion of true negative results of M3/FIT among those with no adenoma detected in colonoscopy (year 3)

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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