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临床试验/NCT03548740
NCT03548740Unknown不适用

Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection and Cervical Cytological Abnormalities.

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
151
试验地点
1
主要终点
Vaginal microbiota and HR-HPV infection

研究概览

简要总结

Since other genital infections enhance HIV susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of HPV infection, cervical cytological abnormalities.

详细描述

Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not sufficient for the development of cervical cancer. Additional factors correlated with HPV persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and, more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of anaerobic bacterial species. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions. And the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of HR-HPV results.

排除标准

  • Clinical diagnosis of vaginitis, immune disease, malignancy History of cervical lesions Pregnancy Clinical diagnosis of other serious systemic primary diseases, such as severe liver and kidney dysfunction Severe mental illness

结局指标

主要结局

Vaginal microbiota and HR-HPV infection

时间窗: 12 months

The persistence vaginal organism in HPV infection participants

Vaginal microbiota and the cervical lesion

时间窗: 12 to 36 months

The cervical cytology, HPV and the vaginal microbiota were evaluated

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

shuwang

Associate Professor

Peking Union Medical College Hospital

研究点 (1)

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