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

NCT04694495CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Zhujiang Hospital

Enrollment

7500

Start Date

2020-11-12

Completion Date

2024-12-31

Study Type

OBSERVATIONAL

Official Title

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

Interventions

16S rRNA gene sequencing of cervical secretions

Conditions

Papillomavirus InfectionsUterine Cervical NeoplasmsSexual Transmitted Disease

Eligibility

Age Range

18 Years – 50 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

Time frame: basline and month 6

Locations

The First Affiliated Hospital of USTC, Hefei, China

The First Hospital of Lanzhou University, Lanzhou, China

Chaozhou Central Hospital, Chaozhou, China

Dongguan People's Hospital, Dongguan, China

Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine, Foshan, China

Zhujiang Hospital, Guangzhou, China

Nanfang Hospital, Guangzhou, China

Taihe Branch of Nanfang Hospital, Guangzhou, China

The First Affiliated Hospital of Jinan University, Guangzhou, China

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China

The Third Affiliated Hospital of Southern Medical University, Guangzhou, China

Huizhou Municipal Central Hospital, Huizhou, China

Peking University Shenzhen Hospital, Shenzhen, China

Shenzhen Hospital of Guangzhou University of Chinese Medicine, Shenzhen, China

Shenzhen Luohu Hospital Group Luohu People's Hospital, Shenzhen, China

The Seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, China

The Third People's Hospital of Shenzhen, Shenzhen, China

Xiaolan People's Hospital of Zhongshan, Zhongshan, China

The First Affiliated Hospital, Sun Yat-Sen Univeristy, Guangzhou, China

Zhuhai Women and Children's Hospital, Zhuhai, China

The Affiliated Hospital of Guizhou Medical University, Guiyang, China

The First People's Hospital of Zunyi, Zunyi, China

Yue Bei People's Hospital, Shaoguan, China

Hainan General Hospital, Haikou, China

The Second Hospital of Hebei Medical University, Shijiazhuang, China

The First Hospital fo Qiqihar, Qiqihar, China

The Second People's Hospital of Lianyungang, Lianyungang, China

Jilin Central General Hospital, Jilin, China

General Hospital of Ningxia Medical University, Yinchuan, China

Qinghai Red Cross Hospital, Xining, China

Jinan Central Hospital, Jinan, China

Obstetrics&Gynecology Hospital of Fudan University, Shanghai, China

Changzhi People's Hospital, Changzhi, China

The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, China

The Affiliated Hospital of Southwest Medical University, Luzhou, China

Tibet Autonomous Region People's Hospital, Lhasa, China

Yan'an Hospital of Kunming City, Kunming, China

Sir Run Run Shaw Hospital, Hanzhou, 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

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