跳至主要内容
临床试验/NCT03809247
NCT03809247招募中不适用

Microbial Diversity of Pancreatic Diseases

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2019年2月1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
330
试验地点
1
主要终点
16sRNA and metagenomics

研究概览

简要总结

This study plans to analyze the digestive flora structure of the group of patients with pancreatic cancer.

The investigators compared the microflora of pancreatic cancer with other pancreatic diseases and healthy people,in order to obtatin the information of microbial community difference among the different groups. Finally,the investigators hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.

详细描述

First, all the participants provided written informed consent for participating in the study. And the collecting procedures have no intervention or impact on treatment measures.

Second,the samples are collected, including the stools, the peripheral blood, and other digestive secretions. If the participants had surgical indications and received surgical treatment, the surgical resections of tissues (including paraffin section) are also collected.

Third, the participants were basically divided into three groups,cases with pancreatic cancer, cases with other pancreatic diseases, and health volunteers.

Finally, the investigators compare the microflora , its metabolites or effects among the different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues ( (including paraffin section)) and so on, and hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
3 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 3 years old, ≤ 85 years old;
  • After MDT discussion, routine surgery or ERCP can be performed, and the postoperative pathology is clear as pancreatic cancer and other pancreatic diseases;
  • There is no serious damage to heart, liver and kidney function;

排除标准

  • Women who are breast-feeding during pregnancy and after pregnancy;
  • Patients with evidence of sensory or motor neuropathy;
  • Those who have a clear cardiovascular disease, severe associated disease or active infection, including known HIV infection;
  • Those who have a history of other cancers;
  • Those who are allergic to drugs or their excipients

结局指标

主要结局

16sRNA and metagenomics

时间窗: 12/2022

Obtain intestinal microbial information from patients with pancreatic cancer and other pancreatic diseases, and obtain information on microbial community structure, evolutionary relationships, and microbial and environmental correlations in intestinal environment samples(weight in grams). Correlate the patient's microbial profile with the pathogenesis of the patient to obtain biomarkers related to the pathogenesis.

次要结局

未报告次要终点

研究者

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

WeiWang

Chief physician

Ruijin Hospital

研究点 (1)

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