Pelvic Microbiomes of Benign and Malignant Ovarian Diseases

Ovarian Neoplasms Clinical Trial

— MTBOD-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03388996
• Other study ID #: MTBOD-1
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, MD
• Phone: 008613911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Laparoscopy procedures

• Specific pathological diagnosis

Exclusion Criteria:

• Previous history of pelvic surgeries

• Evidences of pelvic inflammation diseases

Related Conditions & MeSH terms

• Microbiota
• Ovarian Diseases
• Ovarian Neoplasms
• Ribosome Alteration

Intervention

Diagnostic Test:
• microbiomes
16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Lei Li	Academy Military Medical Science, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of species distribution of microorganism according to 16s RNA analysis	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	2 years
Primary	Difference of species distribution of microorganism according to microculture outcomes	Difference of species distribution of microorganism according to microculture outcomes between control group and study group, and between different sampling sites in each arm	2 years