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临床试验/NCT03786601
NCT03786601Unknown不适用

High-risk HPV Infection and Vaginal Microbiota in Postmenopausal Women

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年12月25日最近更新:
适应症

试验速览

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

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 in postmenopausal women.

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. Owing to the decrease of estrogen level and cervical atrophy in postmenopausal women, cervical cytology is more prone to abnormal changes than in premenopausal women. Clinically, cervical lesions in elderly women are easily neglected. Therefore, cervical cancer in the elderly is usually found in advanced stage, with poor prognosis and more complications of treatment. Based on this, the investigators are going to analyze the changes of microbiota in women with high-risk HPV and the cervical lesions in menopausal women. 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
20 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Those are aged 20 to 75 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

Vaginal microbiota and HR-HPV infection in menopausal women

时间窗: 6 months

The persistence vaginal organism in HPV infection menopausal women

次要结局

  • The difference of vaginal microbiota in different age groups(6 months)

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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