NCT04968548进行中（未招募）不适用
Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Nucleix Ltd.
- 入组人数
- 5,000
- 试验地点
- 31
- 主要终点
- Collection of blood samples
研究概览
简要总结
This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer.
详细描述
This is a prospective, case-control, multi-center, observational nonsignificant risk study. The study aims to collect blood and clinical data from subjects undergoing Low Dose CT (LDCT) for lung cancer screening and subjects with confirmed lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Collection of blood samples
时间窗: 24 Months
Collect blood to support the development and validation of a multi analyte test for lung cancer screening
Clinical data collection
时间窗: 24 Months
Collect clinical data to support the development and validation of a multi analyte test for lung cancer screening
次要结局
- Specificity(36 Months)
- Negative Predictive Value(36 Months)
- Performance(36 Months)
- Sensitivity(36 Months)
- Positive Predictive Value(36 Months)
研究者
研究点 (31)
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