NCT05405673

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

June 29, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

3 years

First QC Date

June 1, 2022

Last Update Submit

August 26, 2024

Conditions

Colorectal CancerColorectal NeoplasmsColorectal Adenoma

Keywords

FITBacterial gene markerColonoscopy

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of bacterial gene markers panel (M3)

    The proportion of subjects with true positive results of M3 among those with one of more advanced neoplasia detected in the index colonoscopy.

    1 month

  • Sensitivity of FIT/FOBT

    The proportion of subjects with true positive results of FIT among those with one of more advanced neoplasia detected in the index colonoscopy.

    1 month

Secondary Outcomes (13)

  • Sensitivity of M3 for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers

    1 month

  • Sensitivity of FIT/FOBT for early-stage (stage 1) or invasive (stage 2-4) colorectal cancers

    1 month

  • Sensitivity of FIT/FOBT for advanced adenomas

    1 month

  • Sensitivity of M3 for advanced adenomas

    1 month

  • Sensitivity of FIT/FOBT for all adenomas

    1 month

  • +8 more secondary outcomes

Study Arms (1)

Colorectal neoplasia screening/surveillance cohort

Subjects with average risk of colorectal neoplasias requiring screening/surveillance colonoscopy

Diagnostic Test: Fecal immunochemical test (FIT)

Interventions

Fecal immunochemical test (FIT)DIAGNOSTIC_TEST

A kind of stool test

Also known as: Bacterial gene marker test
Colorectal neoplasia screening/surveillance cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with average risk of colorectal neoplsia requring screening/surveillance colonoscopy

You may qualify if:

  • 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.

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Connie Seto

CONTACT

6049 0760waiyiseto@cuhk.edu.hk

Min Dai

CONTACT

6049 0760mindai@link.cuhk.hk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (clinical)

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

June 29, 2022

Primary Completion

June 15, 2025

Study Completion

December 31, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)