Actively Recruiting
Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy
Led by Peking Union Medical College Hospital · Updated on 2025-07-01
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the characteristics of intestinal microbiota in patients who have a high risk of colorectal polyp recurrence after polypectomy. The study aims to understand how the microbial communities in the intestinal mucosal tissue relate to disease development and to develop a prediction tool based on microbiota and metabolites. This research is important for uncovering the causes of adenoma recurrence and improving future patient care. Participants undergoing colonoscopy with high-risk colorectal polyps will have 1-2 samples of large intestinal mucosa collected from the polyp and surrounding normal tissue. Stool samples and baseline information such as age, gender, and eating habits will also be gathered. Each patient will be followed for 3 years, with surveillance colonoscopies performed to check for polyp recurrence. Additional biopsies and stool samples will be collected at follow-up colonoscopies if possible, with all samples stored for microbiota sequencing and metabolomic analysis. During the study, researchers will assess the characteristics of intestinal microbiota at 24 months and develop a microbiota- and metabolite-based model to predict polyp recurrence over 36 months. Participants will provide samples and information throughout the follow-up period, allowing for detailed analysis of microbial changes and their relationship to recurrence. This observational study does not involve treatment but focuses on monitoring and collecting data over time to improve understanding of colorectal polyp recurrence.
CONDITIONS
Brief Title
Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40 to 75 years
- Underwent colonoscopy with at least one advanced premalignant polyp or three or more adenomas
You will not qualify if you...
- Severe physical diseases preventing adherence to examination requirements
- Coagulopathy or other contraindications for biopsy or polypectomy
- Previous gastrointestinal tract surgery
- Presence of colorectal cancer or other malignant tumors at baseline
- Presence of inflammatory bowel disease or hereditary polyposis syndromes such as family adenomatous polyposis or Lynch syndrome
- Use of oral antibiotics or probiotics within 1 month before enrollment
- Inability to provide informed consent or refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 years
Participants who undergo colonoscopy with presence of high-risk colorectal polyps are observed for recurrence. Biological samples including biopsies and stool are collected at baseline and during surveillance colonoscopy when allowed.
Initial baseline visit and follow-up visits during surveillance colonoscopy
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing, China
Beijing, China, 100730
Actively Recruiting
Research Team
C
Cheng Peng, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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