HPV Infection and Vaginal Microecology in Immunosuppressed Women
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorLan Zhu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
HIV-infected women
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
5 years2
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
Time frame
5 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lan Zhu
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov
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