Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy

Recruiting

• Conditions: Colorectal Polyp; Colorectal Cancer Recurrent; Colorectal Adenoma

• Registration Number: NCT06957626
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The characteristics of the intestinal microbiota in high-risk colorectal polyp recurrence and their relationship with disease pathogenesis have not yet been fully elucidated. This study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of patients after polypectomy with recurrence of colorectal polyps. Additionally, this research holds significant importance for understanding the etiology of adenoma recurrence and develop a microbiota and metabolite-based predicting tool.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-25
• Status Verified: 2025-04
• Study First Submitted: 2025-04-26
• Study First Submitted QC: 2025-04-26
• Last Update Submitted: 2025-04-26
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• patients aged 40-75 years who undergo the colonoscopy with at least 1 high-risk colorectal polyp

Exclusion Criteria

• patient with severe physical diseases that prevented them from adhering to the examination requirements,
• patient with coagulopathy or other contraindications for biopsy or polypectomy,
• patient with previous surgical procedures on the gastrointestinal tract,
• presence of colorectal cancer or other malignant tumor at baseline
• presence of inflammatory bowel disease or hereditary polyposis syndromes (such as family adenomatous polyposis or Lynch syndrome)
• within 1 month before enrollment, oral antibiotics and probiotics were taken;
• inability to provide informed consent or refusal to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence	24 months	Analyze the characteristics of the microbiota within the intestinal mucosal tissue of patients with high-risk colorectal polyp recurrence or without recurrence.

Secondary Outcome Measures

Name	Time	Method
Development and validation of Microbiota and metabolite-based model predicting recurrence of high-risk colorectal polyps after polypectomy	36 months	Select the recurrence and non-recurrence of polyps during the follow-up period , and develop and validate the recurrence prediction model according to the differences in intestinal mucosal flora and host gene expression levels.

Trial Locations

Locations (1)

Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing, China; 🇨🇳 Beijing, China