NCT01895517已完成4 期
Randomized Controlled Trial to Evaluate the Efficacy of Concurrent Liquid-based Cytology ( LBC) and HPV DNA Testing Versus LBC Alone for the Primary Cervical Cancer Screening
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan2 个研究点 分布在 1 个国家目标入组 18,471 人开始时间: 2013年6月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18,471
- 试验地点
- 2
- 主要终点
- The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
研究概览
简要总结
The aim of this study is to assess efficacy of the screening with concurrent liquid-based cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 30-64 years old
- •Participants provided written informed consent
排除标准
- •will receive planed HPV DNA testing by local governmental cervical cancer program next six years
- •have had cervical invasive cancer before
- •have undergone cervical conization
- •have undergone hysterectomy
- •have had or have the cytological abnormalities and are under follow-up
- •are pregnant
- •are judged ineligible for this trial by physician
结局指标
主要结局
The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
时间窗: 6 years
次要结局
- The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline(2 years, 4 years, 6 years)
- The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline(2 years, 4 years, 6 years)
- The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline(2 years, 4 years, 6 years)
- The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline(2 years, 4 years, 6 years)
- The number of colposcopy and biopsy performance(6 years)
- The number of cervical cytology performance(6 years)
研究者
研究点 (2)
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