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

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

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Neoplasms; Papillomavirus Infections; Sexual Transmitted Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 7500

Contacts and Locations

Study Locations

• China
  • Changsha, China
    • Changsha Central Hospital
  • Chongqing, China
    • The Third Affiliated Hospital of CQMU
  • Guangzhou, China
    • The Fifth Affiliated Hospital of Guangzhou Medical University
  • Shanghai, China
    • Shanghai East Hospital Tongji University
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated hospital of USTC
  • Gansu
    • Lanzhou, Gansu, China
      • The First Hospital of Lanzhou University
  • Guangdong
    • Chaozhou, Guangdong, China
      • Chaozhou Central Hospital
    • Dongguan, Guangdong, China
      • Dongguan People's Hospital
    • Foshan, Guangdong, China
      • Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine
    • Guangzhou, Guangdong, China
      • Nanfang Hospital
    • Guangzhou, Guangdong, China, 510000
      • Zhujiang Hospital
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Jinan University
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • Taihe Branch of Nanfang Hospital
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital of Guangzhou University of Chinese Medicine
    • Huizhou, Guangdong, China
      • Huizhou Municipal Central Hospital
    • Shenzhen, Guangdong, China
      • Shenzhen Luohu Hospital Group Luohu People's Hospital
    • Shenzhen, Guangdong, China
      • The Third People's Hospital of Shenzhen
    • Shenzhen, Guangdong, China
      • Peking University Shenzhen Hospital
    • Shenzhen, Guangdong, China
      • The Seventh Affiliated Hospital, Sun Yat-sen University
    • Shenzhen, Guangdong, China
      • Shenzhen Hospital of Guangzhou University of Chinese Medicine
    • Zhongshan, Guangdong, China
      • Xiaolan People's Hospital of Zhongshan
  • Guangzhou
    • Guangzhou, Guangzhou, China
      • The First Affiliated Hospital, Sun Yat-sen Univeristy
    • Zhuhai, Guangzhou, China
      • Zhuhai Women and Children's Hospital
  • Guizhou
    • Guiyang, Guizhou, China
      • The Affiliated Hospital of Guizhou Medical University
    • Zunyi, Guizhou, China
      • The First People'S Hospital of Zunyi
  • Gunagdong
    • Shaoguan, Gunagdong, China
      • Yue Bei People's Hospital
  • Hainan
    • Haikou, Hainan, China
      • Hainan General Hospital
  • Hebei
    • Shijia Zhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
  • Hei Longjiang
    • Qiqihar, Hei Longjiang, China
      • The First Hospital fo Qiqihar
  • Jiangsu
    • Lianyungang, Jiangsu, China
      • The Second People's Hospital of Lianyungang
  • Jilin
    • Jilin, Jilin, China
      • Jilin Central General Hospital
  • Ningxia
    • Yinchuan, Ningxia, China
      • General Hospital of Ningxia Medical University
  • Qinghai
    • Xining, Qinghai, China
      • Qinghai Red Cross Hospital
  • Shandong
    • Jinan, Shandong, China
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Obstetrics&Gynecology Hospital of Fudan University
  • Shanxi
    • Changzhi, Shanxi, China
      • Changzhi People's Hospital
    • Xi'an, Shanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Luzhou, Sichuan, China
      • The Affiliated Hospital of Southwest Medical University
  • Tibet
    • Lasa, Tibet, China
      • Tibet Autonomous Region People's Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • Yan'an Hospital of Kunming City
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Peking University First Hospital; LanZhou University; First Affiliated Hospital, Sun Yat-Sen University; The Third Affiliated Hospital of Southern Medical University; Shandong Provincial Hospital; Gansu Provincial Hospital; Henan Provincial People's Hospital; Shanghai East Hospital; The Affiliated Hospital Of Guizhou Medical University; First Hospital of China Medical University; Hainan General Hospital; Jinan Central Hospital; Fujian Maternity and Child Health Hospital; General Hospital of Ningxia Medical University; The Seventh Affiliated Hospital of Sun Yat-sen University; Huizhou Municipal Central Hospital; The Fifth Affiliated Hospital of Southern Medical University; Anhui Provincial Hospital; The Affiliated Hospital Of Southwest Medical University; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; Yuebei People's Hospital; First Affiliated Hospital of Guangxi Medical University; Qinghai Red Cross Hospital; Tibet Autonomous Region People's Hospital; Changzhi People's Hospital; The First People's Hospital of Zunyi; Lianyungang Hospital Affiliated Bengbu Medical College; Zhuhai Center for Maternal and Child Health Care; Fifth Affiliated Hospital of Guangzhou Medical University; Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Hongwei Zhou, Doctor, Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: January 3, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Infections; Communicable Diseases; Uterine Cervical Neoplasms; Papillomavirus Infections
• Other Study ID Numbers: CALM2004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No