Persistent Cervical HPV Infection With Clearance and Vaginal Microbiota
Clinical Study on the Relationship Between Persistent Cervical HPV Infection With Clearance and Vaginal Microbial Community
1 other identifier
observational
240
1 country
1
Brief Summary
Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the persistence infection and clearance of HPV infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
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
February 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedStudy Start
First participant enrolled
April 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2020
CompletedAugust 29, 2019
August 1, 2019
10 months
February 4, 2019
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The relationship between diversity of vaginal microbiota and HR-HPV persistent infection
The persistent specific vaginal organism in HPV persistent infection women
12 months
Study Arms (2)
Group A
High-risk HPV persistent infection more than half a year and reversion
Group B
High-risk HPV non-infection
Interventions
The participants were assigned to different groups according to the results of HPV detection
Eligibility Criteria
The participants sample was referred to the paper already published.
You may qualify if:
- Those are aged 20 to 45 years old, have had vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.
You may not qualify if:
- Those have no vaginal intercourse, and can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 4, 2019
First Posted
March 29, 2019
Study Start
April 11, 2019
Primary Completion
February 11, 2020
Study Completion
February 11, 2020
Last Updated
August 29, 2019
Record last verified: 2019-08