HPV Infection and Vaginal Microecology in Immunosuppressed Women
Study on HPV Infection and Vaginal Microecology in Immunosuppressed Women
1 other identifier
observational
10,000
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Longer than P75 for all trials
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
September 27, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
October 1, 2024
September 1, 2024
5.3 years
September 27, 2024
September 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Detection rate of cervical intraepithelial neoplasia grade 2 or above (CIN2+) in women infected with HIV within 5 years
Detection rate of cervical intraepithelial neoplasia grade 2 or above (CIN2+) in women infected with HIV within 5 years
5 years
Detection rate of cervical intraepithelial neoplasia grade 3 and above (CIN3+) in women infected with HIV within 5 years
Detection rate of cervical intraepithelial neoplasia grade 3 and above (CIN3+) in women infected with HIV within 5 years
5 years
Eligibility Criteria
HIV-infected women
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lan Zhulead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital
Study Record Dates
First Submitted
September 27, 2024
First Posted
October 1, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share