Clinical trial NCT04694495: HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
Official title: HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Papillomavirus Infections
Uterine Cervical Neoplasms
Sexual Transmitted Disease
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: The Affiliated Hospital Of Guizhou Medical University
name: Hainan General Hospital
name: LanZhou University
name: Lianyungang Hospital Affiliated Bengbu Medical College
name: General Hospital of Ningxia Medical University
name: Jinan Central Hospital
name: Tibet Autonomous Region People's Hospital
name: The Affiliated Hospital Of Southwest Medical University
name: Anhui Provincial Hospital
name: The First People's Hospital of Zunyi
name: The Third Affiliated Hospital of Southern Medical University
name: First Affiliated Hospital, Sun Yat-Sen University
name: Zhuhai Center for Maternal and Child Health Care
name: First Affiliated Hospital of Guangxi Medical University
name: Qinghai Red Cross Hospital
name: Changzhi People's Hospital
name: Shanghai East Hospital
name: Fifth Affiliated Hospital of Guangzhou Medical University
name: Huizhou Municipal Central Hospital
name: Nanfang Hospital, Southern Medical University
name: Yuebei People's Hospital
name: The Seventh Affiliated Hospital of Sun Yat-sen University
name: Fujian Maternity and Child Health Hospital
name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Henan Provincial People's Hospital
name: The Fifth Affiliated Hospital of Southern Medical University
name: Shandong Provincial Hospital
name: First Hospital of China Medical University
name: Gansu Provincial Hospital
First posted: 2021-01-05
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: alteration of genital microecology from baseline at month 6
timeFrame: basline and month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Chaozhou
country: China
facility: Chaozhou Central Hospital
state: Guangdong
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Foshan
country: China
facility: Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Taihe Branch of Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Southern Medical University
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Luohu Hospital Group Luohu People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Seventh Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: The Third People's Hospital of Shenzhen
state: Guangdong
city: Zhongshan
country: China
facility: Xiaolan People's Hospital of Zhongshan
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen Univeristy
state: Guangzhou
city: Zhuhai
country: China
facility: Zhuhai Women and Children's Hospital
state: Guangzhou
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Zunyi
country: China
facility: The First People's Hospital of Zunyi
state: Guizhou
city: Shaoguan
country: China
facility: Yue Bei People's Hospital
state: Gunagdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijia Zhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Qiqihar
country: China
facility: The First Hospital fo Qiqihar
state: Hei Longjiang
city: Lianyungang
country: China
facility: The Second People's Hospital of Lianyungang
state: Jiangsu
city: Jilin
country: China
facility: Jilin Central General Hospital
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xining
country: China
facility: Qinghai Red Cross Hospital
state: Qinghai
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Obstetrics&Gynecology Hospital of Fudan University
state: Shanghai
city: Changzhi
country: China
facility: Changzhi People's Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Lasa
country: China
facility: Tibet Autonomous Region People's Hospital
state: Tibet
city: Kunming
country: China
facility: Yan'an Hospital of Kunming City
state: Yunnan
city: Hanzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Changsha
country: China
facility: Changsha Central Hospital
city: Chongqing
country: China
facility: The Third Affiliated Hospital of CQMU
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
city: Shanghai
country: China
facility: Shanghai East Hospital Tongji University
Study officials:
affiliation: Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
name: Hongwei Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
References: