HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,500
- 试验地点
- 42
- 主要终点
- alteration of genital microecology from baseline at month 6
研究概览
简要总结
The purpose of this study to access the relations between genital microecology, HPV infection and cervical intraepithelial neoplasia of childbearing-age female in China
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
alteration of genital microecology from baseline at month 6
时间窗: 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.
次要结局
未报告次要终点
研究者
Muxuan Chen
Diagnostic Technician
Zhujiang Hospital