NCT04694495

HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,500 (actual)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study to access the relations between genital microecology, HPV infection and cervical intraepithelial neoplasia of childbearing-age female in China

Detailed description

The volunteers will be recruited from the women who come to the hospital to do the thinprep cytologic test. After being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire. Then, cervical and vaginal swabs and cervical exfoliated cells will be taken from each volunteer to perform 16S rRNA gene sequencing microecology assessment on cervical secretions and detection and genotyping of HPV and pathogens of sexually transmitted diseases. If there is something abnormal with the diagnostic outcomes in the previous examinations, according to the doctor's judgement, those volunteer will be asked to undergo a vaginoscope and a cervical biopsy to evaluate the grade of cervical intraepithelial neoplasia. After six months since the entry, each volunteer will be asked to go back to each research center to do the same sampling and examination as previously did in entry.

Conditions

• Papillomavirus Infections
• Uterine Cervical Neoplasms
• Sexual Transmitted Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	16S rRNA gene sequencing of cervical secretions	1. 16S rRNA gene sequencing of vaginal secretions: using NGS technology to assess the microbiota of the vaginal secretions 2. Microecology assessment of vaginal secretions: morphology test, functional assessment and Nugent score assessment of the vaginal secretions are included. 3. Genotyping of HPV and detection of sexually transmitted diseases pathogens based on the cervical exfoliated cells 4. Thinprep cytologic test of cervical exfoliated cells: to evaluate the grade of cervical intraepithelial neoplasia

Timeline

• Start date: 2020-11-12
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-01-05
• Last updated: 2025-06-27

Locations

42 sites across 1 country: China