Investigating the Gut Microbiota of Individuals With Adenoma, Advanced Adenoma and Colorectal Cancer

NCT07321548 | Completed

• 1 other identifier: CREC 2021.036
• Study Type: observational
• Target: 1,757
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to help establish the first molecular test for non-invasive prediction of recurrent adenoma, which will help identify patients at high risk of recurrent adenoma for further colonoscopy examination, and validate the microbial test for CRC screening in different populations.

Conditions

Colorectal Cancer; Colorectal Adenoma; Colorectal Neoplasms

Keywords

Gut Microbiome; Non-invasive Test

Outcome Measures

Primary Outcomes (1)

• Determine the performance of microbial markers in predicting adenoma and CRC

  3 months after stool sample submission

Secondary Outcomes (2)

• Compare microbiome composition between healthy subjects and populations with adenoma, advanced adenoma, and colorectal cancer

  Approximately 1 year after completed subject recruitment of the study

• Delineate the gut microbial community profiles of the population with adenoma, advanced adenoma, and colorectal cancer residing in different geographical locations with different lifestyles

  Approximately 1 year after completed subject recruitment of the study

Study Arms (4)

N

Healthy control

Diagnostic Test: Fecal immunochemical test

nAA

Subject diagnosed with non-advanced adenoma

Diagnostic Test: Fecal immunochemical test

AA

Subject diagnosed with advanced adenoma

Diagnostic Test: Fecal immunochemical test

CRC

Subject diagnosed with colorectal cancer

Diagnostic Test: Fecal immunochemical test

Interventions

Fecal immunochemical test DIAGNOSTIC_TEST

This diagnosis test is commonly used for screening CRC, which can act as an indicator to compare the performance of our new molecular test

AA; CRC; N; nAA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population scheduled for colonoscopy of participating country/city will be invited and recruited in wards, clinics or endoscopy centres.

You may qualify if:

• History of polypectomy or surgical removal of adenoma or CRC within the past 10 years
• Will undergo a scheduled standard colonoscopy examination

You may not qualify if:

• History of inflammatory bowel disease

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Chinese University of Hong Kong: lead
• Mahidol University: collaborator
• Institute of Gastroenterology and Hepatology, Vietnam: collaborator
• National University of Malaysia: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples collected from subjects and the derivatives will be retained

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 7, 2026
• Study Start: March 15, 2021
• Primary Completion: November 30, 2024
• Study Completion: September 30, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)