HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
- Conditions
- Papillomavirus InfectionsUterine Cervical NeoplasmsSexual Transmitted Disease
- Interventions
- Diagnostic Test: 16S rRNA gene sequencing of cervical secretions
- Registration Number
- NCT04694495
- Lead Sponsor
- Zhujiang Hospital
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 7500
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description volunteers from health examination center 16S rRNA gene sequencing of cervical secretions 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 volunteers from gynecology outpatient 16S rRNA gene sequencing of cervical secretions 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
- Primary Outcome Measures
Name Time Method alteration of genital microecology from baseline at month 6 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
Huizhou Municipal Central Hospital
🇨🇳Huizhou, Guangdong, China
The First Affiliated Hospital of USTC
🇨🇳Hefei, Anhui, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Chaozhou Central Hospital
🇨🇳Chaozhou, Guangdong, China
Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Guangdong Provincial Hospital of Intergrated Traditional Chinese and Western Medicine
🇨🇳Foshan, Guangdong, China
Zhujiang Hospital
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Taihe Branch of Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Shenzhen Hospital of Guangzhou University of Chinese Medicine
🇨🇳Shenzhen, Guangdong, China
Shenzhen Luohu Hospital Group Luohu People's Hospital
🇨🇳Shenzhen, Guangdong, China
The Seventh Affiliated Hospital, Sun Yat-sen University
🇨🇳Shenzhen, Guangdong, China
The Third People's Hospital of Shenzhen
🇨🇳Shenzhen, Guangdong, China
Xiaolan People's Hospital of Zhongshan
🇨🇳Zhongshan, Guangdong, China
The First Affiliated Hospital, Sun Yat-Sen Univeristy
🇨🇳Guangzhou, Guangzhou, China
Zhuhai Women and Children's Hospital
🇨🇳Zhuhai, Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
The First People's Hospital of Zunyi
🇨🇳Zunyi, Guizhou, China
Yue Bei People's Hospital
🇨🇳Shaoguan, Gunagdong, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The Second Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, Hebei, China
The First Hospital fo Qiqihar
🇨🇳Qiqihar, Hei Longjiang, China
The Second People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Jilin Central General Hospital
🇨🇳Jilin, Jilin, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Qinghai Red Cross Hospital
🇨🇳Xining, Qinghai, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Obstetrics&Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Changzhi People's Hospital
🇨🇳Changzhi, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
The Affiliated Hospital of Southwest Medical University
🇨🇳Luzhou, Sichuan, China
Tibet Autonomous Region People's Hospital
🇨🇳Lasa, Tibet, China
Yan'an Hospital of Kunming City
🇨🇳Kunming, Yunnan, China
Sir Run Run Shaw Hospital
🇨🇳Hanzhou, Zhejiang, 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