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

January 6, 2026 updated by: Jessie Qiaoyi Liang, Chinese University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer (CRC) is one of the most common malignancies worldwide. CRC is now the commonest cancer and the second cause of cancer death in Hong Kong. Most CRCs begin as small polyps. Some polyps in particular adenomas may gradually develop into cancer. Early detection of cancer can facilitate successful treatment, and early detection of adenomas can prevent and decrease CRC incidence. Therefore, many efforts are being made to screening of colorectal adenoma and cancer, which will benefit public health greatly in Hong Kong and worldwide.

Abnormality in the composition of the gut microbiota has been implicated as a potentially important etiological factor in the initiation and progression of CRC. With the widespread application of metagenomic analyses in the investigation of intestinal microbiota, an increasing number of bacteria have been identified to be positively associated with CRC. Recent basic research has established a critical function for the intestinal microbiota and specific bacterial species, in promoting colorectal tumorigenesis.

Based on the previously identified microbial markers, the investigators have recently proven that fecal microbial markers can also serve in non-invasive diagnosis of recurrent adenoma in post polypectomy patients. The results have shown that, the panel of microbial markers composing of Fusobacterium nucleatum (Fn), Bacteroides clarus (Bc), Clostridium hathewayi (Ch), and the Lachnoclostridium marker m3 shows good diagnostic performance for colorectal adenoma and CRC. Microbial markers can be used to predict risk of adenoma recurrence during follow-up surveillance, with different scoring algorithms and cutoff values as compared to those used for colorectal neoplasm screening. However, only retrospective samples were used in the previous study, and sample size was limited. A prospective study is warranted to verify the accuracy of the microbial test for predicting recurrent adenoma.

Study Type

Observational

Enrollment (Actual)

1757

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • History of inflammatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
N
Healthy control
Diagnostic test: Fecal immunochemical 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
nAA
Subject diagnosed with non-advanced adenoma
Diagnostic test: Fecal immunochemical 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
Subject diagnosed with advanced adenoma
Diagnostic test: Fecal immunochemical 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
CRC
Subject diagnosed with colorectal cancer
Diagnostic test: Fecal immunochemical 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the performance of microbial markers in predicting adenoma and CRC
Time Frame: 3 months after stool sample submission
3 months after stool sample submission

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare microbiome composition between healthy subjects and populations with adenoma, advanced adenoma, and colorectal cancer
Time Frame: Approximately 1 year after completed subject recruitment of the study
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
Time Frame: Approximately 1 year after completed subject recruitment of the study
Approximately 1 year after completed subject recruitment of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Mahidol University
Second Affiliated Hospital, School of Medicine, Zhejiang University
National University of Malaysia
Institute of Gastroenterology and Hepatology, Vietnam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC 2021.036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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