HPV Testing In Polish POpulation-based Cervical Cancer Screening Program - a Randomized Healthcare Policy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33,000
- 试验地点
- 1
- 主要终点
- Detection rate of histologically confirmed CIN2 or worse in each screening arm
研究概览
简要总结
The HIPPO PROJECT is a randomized healthcare study nested in the OCCSP in Poland. This project will assess the performance of the new screening test (HR HPV test) before its implementation in Poland.
详细描述
The study assumes randomized assumption of 33,000 women aged 30-59 to cytology or HR HPV test in a 1:1 ratio with age stratification (three strata: 30-39, 40-49 and 50-59 years).
Patients are recruited by the Cervical Cancer Prevention Clinic at the Department of Cancer Prevention at the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw (main centre) and 8 more sites from distant regions of Poland (Lublin, Masovian, Silesian, Swietokrzyskie and West Pomeranian Voivodeship). All sites are selected through a tendering process and have to fulfil several criteria for inclusion into the project (active participation in the OCCSP, being certified for HPV testing with the chosen clinically validated hrHPV DNA assays)to obtain results representative for the entire country.
Gynaecological clinics:
Lublin Voivodeship:
- Non-Public Health Care Department MED -SPEC in Zamosc
- Plus Clinic in Zamosc
- Medical Center - Diagnostic in Lukow
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 30-59 with no screening Pap test within the preceding three years in the OCCSP and women with risk factors entitled to annual screening based on information from the SIMP and not tested within preceding 12 months (based on information from the screening database SIMP)
排除标准
- •women with screening Pap test within the preceding three years in the OCCSP
结局指标
主要结局
Detection rate of histologically confirmed CIN2 or worse in each screening arm
时间窗: 12 months after the date of the positive screening test
Detection rate ratio of CIN2+ in HPV test vs cytology arm (and detection rate ratios between the hrHPV test and cytology)
时间窗: 12 months after the date of the positive screening test
This is defined as: number of women with CIN2+ detected in the HPV arm/women screened by HPV ........................................................................................................................... number of women with CIN2+ detected in the cytology arm/women screened in with cytology
次要结局
- Detection rate ratio of CIN1+, CIN3+ (including adeno-carcinoma-in-situ) and cervical cancer (ITT).(12 months after the date of the positive screening test)
- Detection rate ratios of CIN2+ (and CIN1+, CIN3+, cancer) in the per-protocol analysis, restricted to women who adhered to the foreseen follow-up.(12 months after the date of the positive screening test)