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

NCT06957626 | Recruiting

• 1 other identifier: I-23PJ699
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Polyp; Colorectal Cancer Recurrent; Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

• The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence

  Analyze the characteristics of the microbiota within the intestinal mucosal tissue of patients with high-risk colorectal polyp recurrence or without recurrence.

  24 months

Secondary Outcomes (1)

• Development and validation of Microbiota and metabolite-based model predicting recurrence of high-risk colorectal polyps after polypectomy

  36 months

Study Arms (1)

Patients who undergo colonoscopy with precence of high-risk colorectal polyps

For patients who undergo colonoscopy with presence of high-risk colorectal polyps, collect 1-2 pieces of large intestinal mucosa of the polyp and the normal appearing mucosa surrounding the polyp. Collect stool samples and baseline information such as age, gender and eating habit. Each patient will be followed for 3 years, and colonoscopy will be reviewed to determine the recurrence. Biopsies of large intestinal mucosa and stools will be collected at surveillance colonoscopy (follow-up) if allowed. All the samples are stored at -80°C by the study team until the time of DNA extraction for microbiota sequencing analysis and/or metabolomic analysis.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with high-risk colorectal polyps

You may qualify if:

• patients aged 40-75 years who undergo the colonoscopy with at least 1 advanced premalignant polyps or ≥ 3 adenoma

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

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

Beijing, 100730, China

RECRUITING

Study Officials

• Jing nan Li, MD, Ph.D

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Cheng Peng, MD

CONTACT

+86 18500743525; pengchengf@mail.sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Professor

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: April 25, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)