NCT07321548

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,757 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Colorectal Cancer
• Colorectal Adenoma
• Colorectal Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-15
• Primary completion: 2024-11-30
• Completion: 2025-09-30
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Hong Kong