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Completed

NCT Number: NCT07321548

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Adenoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Determine the performance of microbial markers in predicting adenoma and CRC

    Time frame: 3 months after stool sample submission

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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