CTRI/2013/09/003986招募中不适用
Prevalence, Genotype Distribution of HPV in Cervical Infection, and attribution of HPV types to Cervical Intraepithelial Neoplasia and Cervical Cancer in Indian Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 4
- 主要终点
- Prevalence of specific HPV types for each cervical pathology status
研究概览
简要总结
A multicenter prospective surveillance study in Indian women to estimate the prevalence of HPV infection and genotype distribution in Cervical infection, Cervical Intraepithelial Neoplasia (CIN) and Cervical cancer. The study will be conducted in approximately 2000 adult women aged 18 – 60 years visiting Gynecology outpatient departments at hospitals and community centres across India. Cervical samples will be collected from all the subjects and sent to the lab for cervical cytology and HPV DNA testing.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •â€¢Adult women aged 18 – 60 years, •With or without history of cervical intraepithelial neoplasia lesion or Cervical cancer; •Willing to give Informed consent.
排除标准
- •â€¢Subject is pregnant •Previous vaccination against HPV.
结局指标
主要结局
Prevalence of specific HPV types for each cervical pathology status
时间窗: Upon subject enrollment in the study (visit 1; single time point)
次要结局
- Attribution rates of specific HPV types for each cervical pathology status(Upon subject enrollment in the study(visit 1; single time point))
研究者
研究点 (4)
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