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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Papillomavirus Infections, Uterine Cervical Neoplasms, Sexual Transmitted Disease

Intervention / Treatment
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* Diagnostic Test: 16S rRNA gene sequencing of cervical secretions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| volunteers from health examination center<br>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 | Diagnostic Test: 16S rRNA gene sequencing of cervical secretions<br>* 16S rRNA gene sequencing of vaginal secretions: using NGS technology to assess the microbiota of the vaginal secretions Microecology assessment of vaginal secretions: morphology test, functional assessment and Nugent score assessment of the vaginal secretions are included. Genotyping of HPV and detection of sexually transmitted diseases pathogens based on the cervical exfoliated cells Thinprep cytologic test of cervical exfoliated cells: to evaluate the grade of cervical intraepithelial neoplasia<br>* Other names: Thinprep cytologic test of cervical exfoliated cells;|
| volunteers from gynecology outpatient<br>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 | Diagnostic Test: 16S rRNA gene sequencing of cervical secretions<br>* 16S rRNA gene sequencing of vaginal secretions: using NGS technology to assess the microbiota of the vaginal secretions Microecology assessment of vaginal secretions: morphology test, functional assessment and Nugent score assessment of the vaginal secretions are included. Genotyping of HPV and detection of sexually transmitted diseases pathogens based on the cervical exfoliated cells Thinprep cytologic test of cervical exfoliated cells: to evaluate the grade of cervical intraepithelial neoplasia<br>* Other names: Thinprep cytologic test of cervical exfoliated cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alteration of genital microecology from baseline at month 6 | Genital microecology includes measurements of cervical microbiota, HPV and other sexually transmitted diseases pathogens infection status, conditions of the vaginal secretion and the grade of cervical intraepithelial neoplasia. As for cervical microbiota, the NGS technology will be used to sequence the 16s rRNA gene of the microbes in the cervical secretion of each volunteers. PCR will be used to detect HPV and other sexually transmitted diseases pathogens. As for the conditions of the vaginal secretion, methods such as manual microscopic inspection, gram stain and enzymology test will be used to do the measurement. Moreover, thinprep cytologic test of cervical exfoliated cells will be performed to evaluate the grade of cervical intraepithelial neoplasia. | basline and month 6 |