Specimen Collection for Multi-Analyte Blood-Test for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs
研究概览
简要总结
De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).
详细描述
The purpose of this study is to define the performance characteristics (sensitivity and specificity) of the Helio Liver Test within a study population of subjects that have been diagnosed with liver cancer at various stages (I to IV) and for control subjects who have been confirmed to not have liver cancer by at least one imaging technique, such as ultrasound, MRI or CT. Control subjects will include patients who are at high-risk for liver cancer and have been recommended to undergo liver cancer surveillance, as well as patients who have non-HCC cancers to determine analytical specificity.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 Years and Older (Adult, Older Adult)
排除标准
- 未提供
结局指标
主要结局
Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs
时间窗: 15 months
performance evaluation at all stages (I through IV)
Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for early stage HCCs (Stage I and II)
时间窗: 15 months
performance evaluation (early stage, Stage I and II)
次要结局
未报告次要终点