Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection

NCT ID: NCT03548740

Last Updated: 2019-02-06

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

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Recruitment Status

UNKNOWN

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-05-20

Brief Summary

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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.

Detailed Description

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Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not sufficient for the development of cervical cancer. Additional factors correlated with HPV persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and, more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of anaerobic bacterial species. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.

Conditions

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Papillomavirus Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Human Papillomavirus

Intervention Type BIOLOGICAL

women with high-risk Human Papillomavirus or not

Group B

No interventions assigned to this group

Interventions

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Human Papillomavirus

women with high-risk Human Papillomavirus or not

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Clinical diagnosis of HR-HPV results.

Exclusion Criteria

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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shuwang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Shu Wang, associated professor

Role: primary

+86-136-7124-6680

Other Identifiers

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WS-1

Identifier Type: -

Identifier Source: org_study_id

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