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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Colorectal Adenoma; Colorectal Cancer Recurrent; Colorectal Polyp

Study type: Observational

Funder types: Other

Identifiers

NCT06957626

I-23PJ699

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

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

Description:

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.