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临床试验/NCT03895866
NCT03895866Unknown不适用

Clinical Study on the Relationship Between Persistent Cervical HPV Infection With Clearance and Vaginal Microbial Community

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年4月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
240
试验地点
1
主要终点
The relationship between diversity of vaginal microbiota and HR-HPV persistent 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 persistence infection and clearance of HPV infection.

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. High-risk HPV cervical infections are common in young, sexually active women. Most of these infections are transient and do not cause clinical symptoms. After 12-30 months of HPV infection, 70-90% of patients can be cleared naturally, but there are still a small number of patients with high-risk HPV infection can not be eliminated by itself and continue to infect, and can develop into cervical intraepithelial neoplasia, eventually progressing to invasive cervical cancer. Persistent infection of high-risk HPV is a necessary condition for the occurrence of cervical cancer and precancerous lesions. Early blocking of persistent infection of high-risk HPV and timely treatment of cervical precancerous lesions are of great significance in preventing the occurrence of cervical cancer. This project intends to study the relationship between vaginal microbial composition and persistent HPV infection, and determine the related strains and their molecular mechanisms, so as to provide new ideas and basis for its treatment.

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
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Those are aged 20 to 45 years old, have had vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.

排除标准

  • Those have no vaginal intercourse, and can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.

结局指标

主要结局

The relationship between diversity of vaginal microbiota and HR-HPV persistent infection

时间窗: 12 months

The persistent specific vaginal organism in HPV persistent infection women

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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