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

Last updated: June 23, 2025
Sponsor: Zhujiang Hospital
Overall Status: Completed

Phase

N/A

Condition

Cervical Cancer

Uterine Disorders

Treatment

16S rRNA gene sequencing of cervical secretions

Clinical Study ID

NCT04694495
CALM2004
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 beforesampling

Exclusion

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 inreproductive tract within 1 month

Study Design

Total Participants: 7500
Treatment Group(s): 1
Primary Treatment: 16S rRNA gene sequencing of cervical secretions
Phase:
Study Start date:
November 12, 2020
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • The First Affiliated Hospital of USTC

    Hefei, Anhui
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu
    China

    Site Not Available

  • Chaozhou Central Hospital

    Chaozhou, Guangdong
    China

    Site Not Available

  • Dongguan People's Hospital

    Dongguan, Guangdong
    China

    Site Not Available

  • Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine

    Foshan, Guangdong
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Taihe Branch of Nanfang Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Third Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Zhujiang Hospital

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Shenzhen Hospital of Guangzhou University of Chinese Medicine

    Shenzhen, Guangdong
    China

    Site Not Available

  • Shenzhen Luohu Hospital Group Luohu People's Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • The Seventh Affiliated Hospital, Sun Yat-sen University

    Shenzhen, Guangdong
    China

    Site Not Available

  • The Third People's Hospital of Shenzhen

    Shenzhen, Guangdong
    China

    Site Not Available

  • Xiaolan People's Hospital of Zhongshan

    Zhongshan, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-Sen Univeristy

    Guangzhou, Guangzhou
    China

    Site Not Available

  • Zhuhai Women and Children's Hospital

    Zhuhai, Guangzhou
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou
    China

    Site Not Available

  • The First People's Hospital of Zunyi

    Zunyi, Guizhou
    China

    Site Not Available

  • Yue Bei People's Hospital

    Shaoguan, Gunagdong
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijia Zhuang, Hebei
    China

    Site Not Available

  • The First Hospital fo Qiqihar

    Qiqihar, Hei Longjiang
    China

    Site Not Available

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu
    China

    Site Not Available

  • Jilin Central General Hospital

    Jilin, Jilin
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia
    China

    Site Not Available

  • Qinghai Red Cross Hospital

    Xining, Qinghai
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Obstetrics&Gynecology Hospital of Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

  • Changzhi People's Hospital

    Changzhi, Shanxi
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan
    China

    Site Not Available

  • Tibet Autonomous Region People's Hospital

    Lasa, Tibet
    China

    Site Not Available

  • Yan'an Hospital of Kunming City

    Kunming, Yunnan
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hanzhou, Zhejiang
    China

    Site Not Available

  • Changsha Central Hospital

    Changsha,
    China

    Site Not Available

  • The Third Affiliated Hospital of CQMU

    Chongqing,
    China

    Site Not Available

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou,
    China

    Site Not Available

  • Shanghai East Hospital Tongji University

    Shanghai,
    China

    Site Not Available

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