HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
1 other identifier
observational
7,500
1 country
42
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Longer than P75 for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 12, 2020
CompletedFirst Submitted
Initial submission to the registry
January 3, 2021
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 27, 2025
June 1, 2025
4.1 years
January 3, 2021
June 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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
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
Interventions
1. 16S rRNA gene sequencing of vaginal secretions: using NGS technology to assess the microbiota of the vaginal secretions 2. Microecology assessment of vaginal secretions: morphology test, functional assessment and Nugent score assessment of the vaginal secretions are included. 3. Genotyping of HPV and detection of sexually transmitted diseases pathogens based on the cervical exfoliated cells 4. Thinprep cytologic test of cervical exfoliated cells: to evaluate the grade of cervical intraepithelial neoplasia
Eligibility Criteria
Volunteers will be recruited from both outpatient department of gynecology and health examination center in each research center
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhujiang Hospitallead
- Peking University First Hospitalcollaborator
- The Affiliated Hospital Of Guizhou Medical Universitycollaborator
- Hainan General Hospitalcollaborator
- LanZhou Universitycollaborator
- Lianyungang Hospital Affiliated Bengbu Medical Collegecollaborator
- General Hospital of Ningxia Medical Universitycollaborator
- Jinan Central Hospitalcollaborator
- Tibet Autonomous Region People's Hospitalcollaborator
- The Affiliated Hospital Of Southwest Medical Universitycollaborator
- Anhui Provincial Hospitalcollaborator
- The First People's Hospital of Zunyicollaborator
- The Third Affiliated Hospital of Southern Medical Universitycollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Zhuhai Center for Maternal and Child Health Carecollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- Qinghai Red Cross Hospitalcollaborator
- Changzhi People's Hospitalcollaborator
- Shanghai East Hospitalcollaborator
- Fifth Affiliated Hospital of Guangzhou Medical Universitycollaborator
- Huizhou Municipal Central Hospitalcollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- Yuebei People's Hospitalcollaborator
- The Seventh Affiliated Hospital of Sun Yat-sen Universitycollaborator
- Fujian Maternity and Child Health Hospitalcollaborator
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicinecollaborator
- Henan Provincial People's Hospitalcollaborator
- The Fifth Affiliated Hospital of Southern Medical Universitycollaborator
- Shandong Provincial Hospitalcollaborator
- First Hospital of China Medical Universitycollaborator
- Gansu Provincial Hospitalcollaborator
Study Sites (42)
The First Affiliated Hospital of USTC
Hefei, Anhui, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Chaozhou Central Hospital
Chaozhou, Guangdong, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine
Foshan, Guangdong, China
Zhujiang Hospital
Guangzhou, Guangdong, 510000, China
Nanfang Hospital
Guangzhou, Guangdong, China
Taihe Branch of Nanfang Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen Hospital of Guangzhou University of Chinese Medicine
Shenzhen, Guangdong, China
Shenzhen Luohu Hospital Group Luohu People's Hospital
Shenzhen, Guangdong, China
The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Xiaolan People's Hospital of Zhongshan
Zhongshan, Guangdong, China
The First Affiliated Hospital, Sun Yat-Sen Univeristy
Guangzhou, Guangzhou, China
Zhuhai Women and Children's Hospital
Zhuhai, Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The First People's Hospital of Zunyi
Zunyi, Guizhou, China
Yue Bei People's Hospital
Shaoguan, Gunagdong, China
Hainan General Hospital
Haikou, Hainan, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Hospital fo Qiqihar
Qiqihar, Hei Longjiang, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Jilin Central General Hospital
Jilin, Jilin, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai Red Cross Hospital
Xining, Qinghai, China
Jinan Central Hospital
Jinan, Shandong, China
Obstetrics&Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Changzhi People's Hospital
Changzhi, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Tibet Autonomous Region People's Hospital
Lhasa, Tibet, China
Yan'an Hospital of Kunming City
Kunming, Yunnan, China
Sir Run Run Shaw Hospital
Hanzhou, Zhejiang, China
Changsha Central Hospital
Changsha, China
The Third Affiliated Hospital of CQMU
Chongqing, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Shanghai East Hospital Tongji University
Shanghai, China
Related Publications (2)
Chen M, Qi C, Qing W, Zhou Z, Zhang Y, Chen R, Hou Y, Ou J; CALM2004 Consortium Investigators; He Y, Zhou H. Vaginal microbiome and sexually-transmitted pathogens in Chinese reproductive-age women: a multicentre cross-sectional and longitudinal cohort study. Nat Commun. 2025 Nov 14;16(1):10002. doi: 10.1038/s41467-025-64917-7.
PMID: 41238551DERIVEDZhang Y, Qing W, Mo W, Chen R, Zhou Z, Hou Y, Shi Y, Qi C, Ou J, Xie L; CALM 2004 Study Group; Wang Y, Zhou H, Chen M. U. Parvum serovars exhibit distinct pathogenicity in Chinese women of childbearing age: a multicentre cross-sectional study. BMC Infect Dis. 2024 Oct 28;24(1):1213. doi: 10.1186/s12879-024-10113-9.
PMID: 39468466DERIVED
Biospecimen
Biospecimen will include cervical and vaginal swabs, cervical exfoliated cells from reproductive tract of the volunteers
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongwei Zhou, Doctor
Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Diagnostic Technician
Study Record Dates
First Submitted
January 3, 2021
First Posted
January 5, 2021
Study Start
November 12, 2020
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
June 27, 2025
Record last verified: 2025-06