Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HPV HC2® Test in Women 30 Years of Age or Older Using LBC ThinPrep® Pap Test Specimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,000
- 主要终点
- Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test
研究概览
简要总结
To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) and the APTIMA® HPV Assay (Hologic) using LBC Specimens (ThinPrep® Pap Test) for the detection of HPV infection and high-grade CIN lesions in a screening population of women 30 years of age or older in Germany.
详细描述
The study is conducted in the areas of Tuebingen, Freiburg and Saarbruecken in Germany. In total, 10.000 ThinPrep® LBC cervical samples were collected from June 2009 to May 2012. Liquid based cytology (LBC) was performed by a central laboratory in Saarbruecken. Human papilloma virus (HPV) testing with the HR HPV HC2® test and APTIMA® HPV Assay were performed at the Section of Experimental Virology, Institute of Medical Virology, University Clinic of Tuebingen, Germany (UKT).
Within a follow-up phase women who tested positive in any test at baseline will be monitored over a period of 10 years.
Study close out visit: In addition, approximately 5 years after baseline ThinPrep® LBC cervical samples will be collected from a random sample of 4000 study participants who tested triple negative at baseline for determination of the longitudinal negative predictive value (NPV) and HPV related disease after a 5 year period. Women who tested positive in any test will undergo colposcopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test
时间窗: Baseline
次要结局
- Prevalence of HR HPV infection by age with HC2® and APTIMA(Baseline, 5 years)
- Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests(Baseline)
- Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests(Baseline)
- Specificity of LBC, HC2® and APTIMA® tests(Baseline, 5 years)
- Sensitivity of LBC, HC2® and APTIMA® tests(Baseline, 5 years)
- Relative risk of cervical disease for positive tested women(Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years)
- Cumulative risk of cervical diseases for positive tested women at 5 years(Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years)
- Cross sectional association between HR HPV infection (HC2® and APTIMA) and LBC diagnosis(Baseline, 5 years)