Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12,527
- 试验地点
- 2
- 主要终点
- Incidence of CIN2/CIN3+ lesions (which includes invasive cancers and in situ adenocarcinomas) found by subsequent screening (i.e. after the enrollment screening round and its associated follow-up).
研究概览
简要总结
Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect.
Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes stratified by grade of CIN (CIN 2 or CIN3+).
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
- Double
入排标准
- 年龄范围
- 32 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 32-38 years old
- •Attending the Swedish population-based organised cervical screening program
排除标准
- •Not providing informed consent
结局指标
主要结局
Incidence of CIN2/CIN3+ lesions (which includes invasive cancers and in situ adenocarcinomas) found by subsequent screening (i.e. after the enrollment screening round and its associated follow-up).
时间窗: On average 4 years post baseline
次要结局
- Secondary outcomes were the incidence of CIN2/CIN3+ lesions at enrollment screening (including associated follow-up) and outcomes stratified by CIN2 and CIN3+ lesions as endpoints.(On average 4 years post baseline)
- Re-analysis of primary and secondary outcomes also after subsequent 3-yearly screening rounds(On average 7, 10, 13 (et cetera) years post base-line)