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

NCT ID: NCT06957626

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-25
• Study Completion Date: 2026-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing-Nan Li

Chief physician, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing nan Li, MD, Ph.D

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Cheng Peng, MD

Role: CONTACT

pengchengf@mail.sdu.edu.cn

+86 18500743525

Facility Contacts

Cheng Peng

Role: primary

pengchengf@mail.sdu.edu.cn

+86 18500743525

Other Identifiers

I-23PJ699

Identifier Type: -

Identifier Source: org_study_id