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

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

Sponsors

Lead Sponsor: Zhujiang Hospital

Collaborator: 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, Sun Yat-sen University
Xiaolan People's Hospital of Zhongshan
Chaozhou Central Hospital
The Third Affiliated Hospital of CQMU
Changsha Central Hospital

Source Zhujiang Hospital
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

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.

Overall Status Recruiting
Start Date 2020-11-12
Completion Date 2021-11-12
Primary Completion Date 2021-03-11
Study Type Observational
Primary Outcome
Measure Time Frame
alteration of genital microecology from baseline at month 6 basline and month 6
Enrollment 10000
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: 16S rRNA gene sequencing of cervical secretions

Description: 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

Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

50 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Hongwei Zhou, Doctor Principal Investigator Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
Overall Contact

Last Name: Muxuan Chen

Phone: +8613580561916

Email: [email protected]

Location
Facility: Status: Contact:
The First Affiliated Hospital of USTC | Hefei, Anhui, China Not yet recruiting Ming Li 18919685630 [email protected]
The First Hospital of Lanzhou University | Lanzhou, Gansu, China Not yet recruiting Haitao Yu 13919846787 [email protected]
Chaozhou Central Hospital | Chaozhou, Guangdong, China Not yet recruiting Zewei Huang 13502633691 [email protected]163.com
Dongguan People's Hospital | Dongguan, Guangdong, China Not yet recruiting Bashan Zhang 13650346580 [email protected]
Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine | Foshan, Guangdong, China Not yet recruiting Chaoxin Jiang 13697461081 [email protected]
Zhujiang Hospital | Guangzhou, Guangdong, 510000, China Recruiting Mu-Xuan Chen 13580561916 [email protected]
Nanfang Hospital | Guangzhou, Guangdong, China Not yet recruiting Lei Zheng 13509612507 [email protected]
Taihe Branch of Nanfang Hospital | Guangzhou, Guangdong, China Not yet recruiting Qunxiang Liu 13926408009 [email protected]
The First Affiliated Hospital of Jinan University | Guangzhou, Guangdong, China Not yet recruiting Taoyu Zhou 13719445576 [email protected]
The Third Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou, Guangdong, China Not yet recruiting Kewei Zhao 13711355225 [email protected]
The Third Affiliated Hospital of Southern Medical University | Guangzhou, Guangdong, China Recruiting Xuefeng Wang 15913130306 [email protected]
Huizhou Municipal Central Hospital | Huizhou, Guangdong, China Not yet recruiting Xianjin Wu 13927326806 [email protected]
Peking University Shenzhen Hospital | Shenzhen, Guangdong, China Not yet recruiting Ling Ji 13714685518 [email protected]
Shenzhen Hospital of Guangzhou University of Chinese Medicine | Shenzhen, Guangdong, China Not yet recruiting Bohai Yu 18813675582 [email protected]
Shenzhen Luohu Hospital Group Luohu People's Hospital | Shenzhen, Guangdong, China Not yet recruiting Xiuming Zhang 13530879898 [email protected]
The Seventh Affiliated Hospital, Sun Yat-sen University | Shenzhen, Guangdong, China Not yet recruiting Zhaofan Luo 18002295130 [email protected]
The Third People's Hospital of Shenzhen | Shenzhen, Guangdong, China Not yet recruiting Jiuxin Qu 13823744830 [email protected]
Xiaolan People's Hospital of Zhongshan | Zhongshan, Guangdong, China Not yet recruiting Guanghui Chen 18928116815 [email protected]
The First Affiliated Hospital, Sun Yat-Sen Univeristy | Guangzhou, Guangzhou, China Not yet recruiting Shuzhong Yao 13602834127 [email protected]
Zhuhai Women and Children's Hospital | Zhuhai, Guangzhou, China Not yet recruiting Gongjun Tan 15989755730 [email protected]
The Affiliated Hospital of Guizhou Medical University | Guiyang, Guizhou, China Not yet recruiting Fan Lu 15508508006 [email protected]
The First People's Hospital of Zunyi | Zunyi, Guizhou, China Not yet recruiting Kaifeng Wu 13788989286 [email protected]
Yue Bei People's Hospital | Shaoguan, Gunagdong, China Not yet recruiting Pingsen Zhao 13332876639 [email protected]
Hainan General Hospital | Haikou, Hainan, China Not yet recruiting Bo Wang 17784613331 [email protected]
The Second Hospital of Hebei Medical University | Shijia Zhuang, Hebei, China Not yet recruiting Xianghua Huang 15803210557 [email protected]
The First Hospital fo Qiqihar | Qiqihar, Hei Longjiang, China Recruiting Hong Chen 17713326955 [email protected]
The Second People's Hospital of Lianyungang | Lianyungang, Jiangsu, China Not yet recruiting Wei Liang 15351883016 [email protected]
Jilin Central General Hospital | Jilin, Jilin, China Not yet recruiting Guijie Zhang 15543430407 [email protected]
General Hospital of Ningxia Medical University | Yinchuan, Ningxia, China Not yet recruiting Feng Li 13895380919 [email protected]
Qinghai Red Cross Hospital | Xining, Qinghai, China Not yet recruiting Dengyun Ma 18997189512 [email protected]
Jinan Central Hospital | Jinan, Shandong, China Not yet recruiting Shuyi Han 18905317293 [email protected]
Obstetrics&Gynecology Hospital of Fudan University | Shanghai, Shanghai, China Not yet recruiting Chunmei Ying 13601694996 [email protected]
Changzhi People's Hospital | Changzhi, Shanxi, China Not yet recruiting Yan Han 15303557209 [email protected]
The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an, Shanxi, China Not yet recruiting Ruifang An 18991232090 [email protected]
The Affiliated Hospital of Southwest Medical University | Luzhou, Sichuan, China Recruiting Jinbo Liu 13989127088 [email protected]
Tibet Autonomous Region People's Hospital | Lasa, Tibet, China Not yet recruiting Zhi Juan 13058038357 [email protected]
Yan'an Hospital of Kunming City | Kunming, Yunnan, China Not yet recruiting Xumei Zhang 13888016593 [email protected]
Sir Run Run Shaw Hospital | Hanzhou, Zhejiang, China Not yet recruiting Jun Zhang 13515813731 [email protected]
Changsha Central Hospital | Changsha, China Not yet recruiting Xuelian Zhang 13975131003 [email protected]
The Third Affiliated Hospital of CQMU | Chongqing, China Not yet recruiting Kun Deng 15923800009 [email protected]
The Fifth Affiliated Hospital of Guangzhou Medical University | Guangzhou, China Not yet recruiting Liang Peng 13460264142 [email protected]
Shanghai East Hospital Tongji University | Shanghai, China Not yet recruiting Jingxin Cheng 18930937930 [email protected]
Location Countries

China

Verification Date

2021-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Zhujiang Hospital

Investigator Full Name: Muxuan Chen

Investigator Title: Diagnostic Technician

Has Expanded Access No
Condition Browse
Arm Group

Label: 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

Label: 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

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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