Pelvic Microbiomes of Benign and Malignant Ovarian Diseases

• Conditions: Ovarian Neoplasms; Ribosome Alteration; Microbiota
• Interventions: Diagnostic Test: microbiomes

• Registration Number: NCT03388996
• Lead Sponsor: Lei Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-31
• Study Start: 2018-01-01
• Study First Posted: 2018-01-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-09
• Last Update Posted: 2018-11-14
• Primary Completion: 2020-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Laparoscopy procedures
• Specific pathological diagnosis

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benign ovarian disease	microbiomes	The group consists of patients of benign ovarian diseases and health conditions (eg infertility), who would accept the tests of pelvic microbiomes.
Malignant ovarian disease	microbiomes	The group consists of patients of high grade serous carcinoma, who would accept the tests of pelvic microbiomes.

Primary Outcome Measures

Name	Time	Method
Difference of species distribution of microorganism according to 16s RNA analysis	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	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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China