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

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ClinicalTrials.gov Identifier: NCT03388996
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Microbiota Ovarian Neoplasms Ribosome Alteration Diagnostic Test: microbiomes

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Role of Pelvic Microbiomes During the Malignant Transformation of Benign Ovarian Diseases
Anticipated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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. 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


Biospecimen Retention:   Samples With DNA
Discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube are going to sent for analysis of 16s RNA.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Laparoscopy procedures
  • Specific pathological diagnosis

Exclusion Criteria:

  • Previous history of pelvic surgeries
  • Evidences of pelvic inflammation diseases
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388996


Contacts
Contact: Lei Li, MD 008613911988831 lileigh@163.com
Contact: Lan Zhu, MD 008613911714696 zhu_julie@vip.sina.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Academy Military Medical Science, China
Investigators
Principal Investigator: Lei Li, MD Peking Union Medical College Hospital
More Information

Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03388996     History of Changes
Other Study ID Numbers: MTBOD-1
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We would share individual participant data to all other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: For ever
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Ovarian Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders