NCT03548740

Brief Summary

Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.

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
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

May 24, 2018

Last Update Submit

February 4, 2019

Conditions

Papillomavirus Infections

Outcome Measures

Primary Outcomes (2)

  • Vaginal microbiota and HR-HPV infection

    The persistence vaginal organism in HPV infection participants

    12 months

  • Vaginal microbiota and the cervical lesion

    The cervical cytology, HPV and the vaginal microbiota were evaluated

    12 to 36 months

Study Arms (2)

Group A

Biological: Human Papillomavirus

Group B

Interventions

Human PapillomavirusBIOLOGICAL

women with high-risk Human Papillomavirus or not

Group A

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Group A: HPV positive, and the participants who have not taken drugs and physical therapy in the past six months, nor have chronic diseases (such as DM), take their vaginal microorganisms (do not mention the past History issues). Group B: HPV negative in the past 12 months, taking the vaginal microorganisms.

You may qualify if:

  • Clinical diagnosis of HR-HPV results.

You may not qualify if:

  • Clinical diagnosis of vaginitis, immune disease, malignancy History of cervical lesions Pregnancy Clinical diagnosis of other serious systemic primary diseases, such as severe liver and kidney dysfunction Severe mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 7, 2018

Study Start

September 1, 2018

Primary Completion

January 20, 2020

Study Completion

May 20, 2020

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations

CN(1)