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

Last updated: July 10, 2024
Sponsor: Zhujiang Hospital
Overall Status: Active - Recruiting

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: 10000
Treatment Group(s): 1
Primary Treatment: 16S rRNA gene sequencing of cervical secretions
Phase:
Study Start date:
November 12, 2020
Estimated Completion Date:
December 12, 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

    Active - Recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu
    China

    Active - Recruiting

  • Chaozhou Central Hospital

    Chaozhou, Guangdong
    China

    Active - Recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong
    China

    Active - Recruiting

  • Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine

    Foshan, Guangdong
    China

    Active - Recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Taihe Branch of Nanfang Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Zhujiang Hospital

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong
    China

    Active - Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • Shenzhen Hospital of Guangzhou University of Chinese Medicine

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • Shenzhen Luohu Hospital Group Luohu People's Hospital

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • The Seventh Affiliated Hospital, Sun Yat-sen University

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • The Third People's Hospital of Shenzhen

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • Xiaolan People's Hospital of Zhongshan

    Zhongshan, Guangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-Sen Univeristy

    Guangzhou, Guangzhou
    China

    Active - Recruiting

  • Zhuhai Women and Children's Hospital

    Zhuhai, Guangzhou
    China

    Active - Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou
    China

    Active - Recruiting

  • The First People's Hospital of Zunyi

    Zunyi, Guizhou
    China

    Active - Recruiting

  • Yue Bei People's Hospital

    Shaoguan, Gunagdong
    China

    Active - Recruiting

  • Hainan General Hospital

    Haikou, Hainan
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijia Zhuang, Hebei
    China

    Active - Recruiting

  • The First Hospital fo Qiqihar

    Qiqihar, Hei Longjiang
    China

    Active - Recruiting

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu
    China

    Active - Recruiting

  • Jilin Central General Hospital

    Jilin, Jilin
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia
    China

    Active - Recruiting

  • Qinghai Red Cross Hospital

    Xining, Qinghai
    China

    Active - Recruiting

  • Jinan Central Hospital

    Jinan, Shandong
    China

    Active - Recruiting

  • Obstetrics&Gynecology Hospital of Fudan University

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Changzhi People's Hospital

    Changzhi, Shanxi
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi
    China

    Active - Recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan
    China

    Active - Recruiting

  • Tibet Autonomous Region People's Hospital

    Lasa, Tibet
    China

    Active - Recruiting

  • Yan'an Hospital of Kunming City

    Kunming, Yunnan
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital

    Hanzhou, Zhejiang
    China

    Active - Recruiting

  • Changsha Central Hospital

    Changsha,
    China

    Active - Recruiting

  • The Third Affiliated Hospital of CQMU

    Chongqing,
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou,
    China

    Active - Recruiting

  • Shanghai East Hospital Tongji University

    Shanghai,
    China

    Active - Recruiting

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