Pelvic Microbiomes of Benign and Malignant Ovarian Diseases

NCT ID: NCT03388996

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Microbiota Ovarian Neoplasms Ribosome Alteration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

microbiomes

Intervention Type DIAGNOSTIC_TEST

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.

microbiomes

Intervention Type DIAGNOSTIC_TEST

16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

microbiomes

16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Laparoscopy procedures
* Specific pathological diagnosis

Exclusion Criteria

* Previous history of pelvic surgeries
* Evidences of pelvic inflammation diseases
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Academy Military Medical Science, China

INDUSTRY

Sponsor Role collaborator

Lei Li

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lei Li, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lei Li, MD

Role: CONTACT

008613911988831

Lan Zhu, MD

Role: CONTACT

008613911714696

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lei Li, MD

Role: primary

008613911988831

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MTBOD-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.