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

NCT ID: NCT07321548

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1757 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer Colorectal Adenoma Colorectal Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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N

Healthy control

Fecal immunochemical test

Intervention Type 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

nAA

Subject diagnosed with non-advanced adenoma

Fecal immunochemical test

Intervention Type 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

Subject diagnosed with advanced adenoma

Fecal immunochemical test

Intervention Type 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

CRC

Subject diagnosed with colorectal cancer

Fecal immunochemical test

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Gastroenterology and Hepatology, Vietnam

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role collaborator

National University of Malaysia

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Jessie Qiaoyi Liang

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CREC 2021.036

Identifier Type: -

Identifier Source: org_study_id

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