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

June 23, 2025 updated by: Muxuan Chen, Zhujiang Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
  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
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
  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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
basline and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hongwei Zhou, Doctor, Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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