NCT03388996

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

December 22, 2017

Last Update Submit

November 9, 2018

Conditions

MicrobiotaOvarian NeoplasmsRibosome Alteration

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

Malignant ovarian disease

The group consists of patients of high grade serous carcinoma, who would accept the tests of pelvic microbiomes.

Diagnostic Test: microbiomes

Interventions

microbiomesDIAGNOSTIC_TEST

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

Benign ovarian diseaseMalignant ovarian disease

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Laparoscopy procedures
  • Specific pathological diagnosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

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.

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Microbiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Lei Li, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, MD

CONTACT

008613911988831lileigh@163.com

Lan Zhu, MD

CONTACT

008613911714696zhu_julie@vip.sina.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 3, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

We would share individual participant data to all other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
For ever

Locations

CN(1)