跳至主要内容
临床试验/NCT03388996
NCT03388996Unknown不适用

The Role of Pelvic Microbiomes During the Malignant Transformation of Benign Ovarian Diseases

Lei Li1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Difference of species distribution of microorganism according to 16s RNA analysis

研究概览

简要总结

This case-control study aims to compare the pelvic microbiomes of benign ovarian diseases and ovarian malignancies by 16s RNA techniques and culture. Discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube are collected from age and menopausal status matched patient before and during procedures of laparoscopies. The discharges/flushing fluid would be sent for 16s RNA analysis and microculture respectively, and the results would get self-contrasted comparison and case-control comparison.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Laparoscopy procedures
  • Specific pathological diagnosis

排除标准

  • Previous history of pelvic surgeries
  • Evidences of pelvic inflammation diseases

结局指标

主要结局

Difference of species distribution of microorganism according to 16s RNA analysis

时间窗: 2 years

The difference of species of microorganism distribution according to 16s RNA sequencing analysis between control group and study group, and between different sampling sites in each arm

Difference of species distribution of microorganism according to microculture outcomes

时间窗: 2 years

Difference of species distribution of microorganism according to microculture outcomes between control group and study group, and between different sampling sites in each arm

次要结局

未报告次要终点

研究者

发起方
Lei Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Li

Professor

Peking Union Medical College Hospital

研究点 (1)

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