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Completed

NCT Number: NCT04694495

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

16S rRNA gene sequencing of cervical secretions

Diagnostic Test
  • 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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2021
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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