Clinical trial · Observational
Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer Recurrent | — | UNRESOLVED | — |
| Colorectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 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.
Primary outcomes (1)
- measure
- The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence
- timeFrame
- 24 months
- description
- Analyze the characteristics of the microbiota within the intestinal mucosal tissue of patients with high-risk colorectal polyp recurrence or without recurrence.
Secondary outcomes (1)
- measure
- Development and validation of Microbiota and metabolite-based model predicting recurrence of high-risk colorectal polyps after polypectomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available