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

Zhujiang Hospital

Status: Completed

Conditions: Uterine Cervical Neoplasms; Papillomavirus Infections; Sexual Transmitted Disease

Treatments: Diagnostic Test: 16S rRNA gene sequencing of cervical secretions

Study type: Observational

Funder types: Other

Identifiers

NCT04694495

CALM2004

Details and patient eligibility

About

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

Full 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.

Enrollment: 7,500 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female of childbearing age conducting thinprep cytologic test
• Having an experience of sexual intercourse
• Not during the menstrual period
• No sexual intercourse or vaginal medication or vaginal flushing in 3 days before sampling

Exclusion criteria

• Within 8 weeks of pregnancy or postpartum
• Having had tumors in reproductive tract
• Having had HPV bivalent, tetravalent or nine-valent vaccination
• Having received treatment for anti- HPV or other STDs pathogens infection
• Having had hysterectomy, cervical surgery and pelvic radiotherapy
• Having used broad-spectrum antibiotics, probiotics or vaginal suppositories in reproductive tract within 1 month

Trial design

7,500 participants in 2 patient groups

volunteers from health examination center

Description:

volunteers(n = 50/center) doing gynecologial examination recruited from health examination center, who shows no symptoms and signs in reproductive tract and are potentially regarded as the healthy controls

Treatment:

Diagnostic Test: 16S rRNA gene sequencing of cervical secretions

volunteers from gynecology outpatient

Description:

volunteers(n = 150/center) recruited from gynecology outpatient, who show abnormal symptoms and signs in reproductive tract and are potentially regarded as the cases with conditions in reproductive tract

Treatment:

Diagnostic Test: 16S rRNA gene sequencing of cervical secretions