HPV Infection and Vaginal Microecology in Immunosuppressed Women

NCT ID: NCT06619743

Last Updated: 2024-10-01

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

NOT_YET_RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2029-12-31

Brief Summary

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This study intends to establish a screening cohort for HPV infection and related tumors in areas with high incidence of HIV infection, explore the screening of cervical cancer and anal cancer and the prognosis management model of precancerous lesions in HIV-infected women, and provide a scientific basis for the formulation of malignant tumor screening policies for this population in my country. In addition, this study intends to characterize the cervical, vaginal, and intestinal microecological characteristics of women with different HIV/HPV infection status, so as to explore the impact of cervical, vaginal, and intestinal microecological characteristics on persistent HPV infection or CIN/cancer progression.

Detailed Description

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Conditions

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HIV Infections HPV Infection Cervical Cancer Anal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* HIV positive female, ≥18 years old
* HIV infection is sexually transmitted
* Have an intact cervix
* Have not received cervical cancer screening in the past 1 year
* No previous treatment for CIN/cervical cancer
* No clinical pregnancy symptoms

Exclusion Criteria

* Women who have had a previous cervical resection
* Unable to complete all screening processes independently
* Unable or unwilling to accept follow-up
* For subjects in vaginal microecology studies, women who used antibiotics within 2 weeks before collecting vaginal secretions, had sexual intercourse within 3 days, or used vaginal medication or vaginal douching within 48 hours need to be further excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lan Zhu

OTHER

Sponsor Role lead

Responsible Party

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Lan Zhu

Director of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Roujie Huang

Role: CONTACT

+8618373153750

Lan Zhu, MD

Role: CONTACT

Other Identifiers

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K6758

Identifier Type: -

Identifier Source: org_study_id

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