Pelvic Microbiomes of Benign and Malignant Ovarian Diseases (MTBOD-1)

November 9, 2018 updated by: Lei Li

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Group of benign ovarian diseases: patients with definite benigh ovarian diseases or health conditions (eg infertlity)

Group of malignant ovarian diseases: patients with definite diagnosis of high grade serous carcinoma

Description

Inclusion Criteria:

  • Laparoscopy procedures
  • Specific pathological diagnosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benign ovarian disease
The group consists of patients of benign ovarian diseases and health conditions (eg infertility), who would accept the tests of pelvic microbiomes.
Diagnostic test: microbiomes
16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube
Malignant ovarian disease
The group consists of patients of high grade serous carcinoma, who would accept the tests of pelvic microbiomes.
Diagnostic test: microbiomes
16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of species distribution of microorganism according to 16s RNA analysis
Time Frame: 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
2 years
Difference of species distribution of microorganism according to microculture outcomes
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lei Li

Collaborators

Academy Military Medical Science, China

Investigators

  • Principal Investigator: Lei Li, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

December 31, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTBOD-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We would share individual participant data to all other researchers

IPD Sharing Time Frame

For ever

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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