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

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ClinicalTrials.gov Identifier: NCT04694495

Recruitment Status : Recruiting

First Posted : January 5, 2021

Last Update Posted : August 3, 2021

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Sponsor:

Collaborators:

Peking University Hospital

The Affiliated Hospital Of Guizhou Medical University

Hainan People's Hospital

LanZhou University

Lianyungang Hospital Affiliated Bengbu Medical College

General Hospital of Ningxia Medical University

Jinan Central Hospital

First Affiliated Hospital Xi'an Jiaotong University

Tibet Autonomous Region People's Hospital

The Affiliated Hospital Of Southwest Medical University

Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region

Yan'an Hospital of Kunming City

The First Affiliated Hospital of University of Science and Technology of China

Zunyi First People's Hospital

Peking University Shenzhen Hospital

Dongguan People's Hospital

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine

The Third Affiliated Hospital of Southern Medical University

Taihe Branch of Nanfang Hospital

First Affiliated Hospital, Sun Yat-Sen University

Shenzhen Luohu Hospital Group Luohu People's Hospital

Zhuhai Center for Maternal and Child Health Care

Obstetrics & Gynecology Hospital of Fudan University

First Affiliated Hospital of Guangxi Medical University

The Second Hospital of Hebei Medical University

Jilin Central General Hospital

The First Hospital fo Qiqihar

Qinghai Red Cross Hospital

Changzhi People's Hospital

Shanghai East Hospital Tongji University

Sir Run Run Shaw Hospital

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine

The Fifth Affiliated Hospital of Guangzhou Medical University

Shenzhen Hospital of Guangzhou University of Chinese Medicine

Huizhou Municipal Central Hospital

First Affiliated Hospital of Jinan University

Nanfang Hospital of Southern Medical University

Shenzhen Third People's Hospital

Yuebei People's Hospital

The Seventh Affiliated Hospital of Sun Yat-sen University

Xiaolan People's Hospital of Zhongshan

Chaozhou Central Hospital

The Third Affiliated Hospital of CQMU

Changsha Central Hospital

Information provided by (Responsible Party):

Muxuan Chen, Zhujiang Hospital

Study Description

Brief 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

Condition or disease	Intervention/treatment
Papillomavirus Infections Uterine Cervical Neoplasms Sexual Transmitted Disease	Diagnostic Test: 16S rRNA gene sequencing of cervical secretions

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.

Study Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	10000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
Actual Study Start Date :	November 12, 2020
Estimated Primary Completion Date :	December 11, 2021
Estimated Study Completion Date :	December 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genes and Gene Therapy

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
volunteers from health examination center 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 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 Other Names: Microecology assessment of cervical secretions Genotyping of HPV and detection of sexually transmitted diseases pathogens Thinprep cytologic test of cervical exfoliated cells
volunteers from gynecology outpatient 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 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 Other Names: Microecology assessment of cervical secretions Genotyping of HPV and detection of sexually transmitted diseases pathogens Thinprep cytologic test of cervical exfoliated cells

Group/Cohort

Intervention/treatment

volunteers from health examination center

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

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

Other Names:

Microecology assessment of cervical secretions
Genotyping of HPV and detection of sexually transmitted diseases pathogens
Thinprep cytologic test of cervical exfoliated cells

volunteers from gynecology outpatient

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

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

Other Names:

Microecology assessment of cervical secretions
Genotyping of HPV and detection of sexually transmitted diseases pathogens
Thinprep cytologic test of cervical exfoliated cells

Outcome Measures

Primary Outcome Measures :

alteration of genital microecology from baseline at month 6 [ Time Frame: basline and 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.

Biospecimen Retention: Samples With DNA

Biospecimen will include cervical and vaginal swabs, cervical exfoliated cells from reproductive tract of the volunteers

Eligibility Criteria

Information from the National Library of Medicine

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Layout table for eligibility information

Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Volunteers will be recruited from both outpatient department of gynecology and health examination center in each research center

Criteria

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

Contacts and Locations