VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 23,941
- 试验地点
- 1
- 主要终点
- Sensitivity of the index triage test: Pap-test
研究概览
简要总结
Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women participating in a cervical cancer screening program using an HPV assay as primary screening test
- •positivity to hrHPV;
- •written informed consent given.
排除标准
- •total hysterectomy;
- •diagnosis of CIN2+ in the last two years;
- •hrHPV negative or inadequate.
结局指标
主要结局
Sensitivity of the index triage test: Pap-test
时间窗: Baseline
Sensitivity of the index triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage and relative sensitivity (index vs comparator)
Sensitivity of the index and comparator triage test: HPV molecular test
时间窗: Baseline
Sensitivity of the index and comparator triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage + delayed triage; and relative sensitivity (index vs comparator).
Specificity of the index and comparator triage test
时间窗: Month 12
Specificity of the index and comparator triage test(s) performed at the time of reflex testing for \<CIN2 considered at the time of reflex triage accepting negative colposcopy at the time of reflex testing and double negative index triage testing (reflex and delayed) as an acceptable proxy for \<CIN2 and relative specificity for \<CIN2 (index vs comparator).
次要结局
未报告次要终点