Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopic Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of detection of pre-cancerous lesions using Hologic Genius Digital Cytology Imaging scanner.
研究概览
简要总结
Quality assurance of the laboratory examinations. Prospective non-interventional study with ThinPrep slides collected during the German Co-Screening Program and routinely sent to the lab to prospectively evaluate the clinical performance of the Hologic Genius Digital Cytology (DC) system vs. the liquid-based cytology (LBC) manual microscopic approach
详细描述
The cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (HPV). Cytology has been the gold standard for cervical screening since the introduction of routine screening with the Pap test in the 1950s due to its effect on mortality in regions with screening programs. Since that time, there have been several technological advances (LBC, Imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. The Hologic's Genius Digital Diagnostics System is a CE-IVD (CE-marked in vitro diagnostic device) marked digital cytology platform. For quality assurance and to prospectively evaluate the Hologic Genius Digital Cytology (DC) system in the lab, selected routinely screened and already archived slides will be additionally reviewed with the liquid-based cytology (LBC) manual microscopic approach. Only anonymized results will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory Zotz & Klimas as part of the German Cervical cancer screening program.
排除标准
- 未提供
结局指标
主要结局
Sensitivity and specificity of detection of pre-cancerous lesions using Hologic Genius Digital Cytology Imaging scanner.
时间窗: 1 year
To demonstrate non-inferiority, the appropriate approximative one-sided 95% confidence interval for the true difference between the two approaches (Digital Cytology and Manual microscopic reading) will be constructed.
次要结局
- Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.(1 year)
- Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.(1 year)
- To assess the rate of inadequate slides that cannot be read by the Hologic Genius Digital Cytology system.(1 year)