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临床试验/NCT06957626
NCT06957626招募中不适用

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

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 24 months

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

次要结局

  • Development and validation of Microbiota and metabolite-based model predicting recurrence of high-risk colorectal polyps after polypectomy(36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing-Nan Li

Chief physician, Professor

Peking Union Medical College Hospital

研究点 (1)

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