Helio Liver Test Case-Controlled Performance Study in China (HEPATIC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,556
- 试验地点
- 2
- 主要终点
- evaluate sensitivity and specificity of Helio Liver Test
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has provided informed consent to participate in the study
- •The subject is 18 to 75 years old (inclusive)
- •For subjects diagnosed with HCC, the subject must meet the following criteria:
- •The subject must have active HCC at the time of the blood draw
- •The subject has not undergone treatment for HCC
- •For subjects diagnosed with primary liver cancer, the subject has been recently diagnosed (within 3 months of enrollment) to have HCC by at least one of the following methods:
- •Subject has a ≥1 cm lesion that is indicated to be HCC by MRI or CT due to exhibiting arterial phase hyperenhancement in combination with washout appearance
- •Subject has a lesion of any size that is indicated to be HCC due to capsule appearance by 4 phase CT scan or multiphase contrast enhanced MRI
- •Subject has a biopsy that is positive for HCC
- •Diagnostic imaging by multiphasic MRI or CT indicates a suspicious lesion on the liver, which is subsequently confirmed to be HCC by another method (biopsy, or surgical pathology) within 3 months from the blood draw
- •For subjects without liver cancer, the subject is confirmed NOT to have liver cancer by at least one of the following methods within 3 months of the blood draw
- •Ultrasound result is negative for HCC or suspicious lesions
- •Diagnostic imaging by multiphasic MRI or CT clearly indicates the subject does not have HCC
排除标准
- •Subject has previously been diagnosed with a primary liver cancer
- •Subject has previously received any treatment for HCC prior to enrollment/blood sample collection, including: surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC
- •Subject has undergone prior or current treatment for HCC with sorafenib, regorafenib, or other treatment indicated for HCC.
- •Subject has received a cancer diagnosis within the past 5 years for any cancer (with the exceptions of basal cell or squamous cell skin cancers).
- •Subject has received treatment for any cancer, including chemotherapy and/or radiation therapy, within 5 years prior to enrollment/sample collection.
- •Subject have received IV contrast dye (for multiphasic CT or MRI) within 1 day [or 24 hours] of blood collection.
- •Subject has undergone fine needle aspiration (FNA) of target pathology withing 3 days prior to blood collection.
- •Subject has undergone a biopsy (other than FNA) of target pathology withing 7 days prior to blood collection.
结局指标
主要结局
evaluate sensitivity and specificity of Helio Liver Test
时间窗: enrollment period
To evaluate the performance characteristics (sensitivity and specificity) of the Helio Liver Test within a population of subjects diagnosed with HCC or Control Subjects who are at high-risk of HCC due to a benign liver condition.
次要结局
- secondary subset analysis for sensitivity(enrollment period)
- secondary subset for sensitivity and specificity by severity of liver cirrhosis(enrollment period)
- secondary subset analysis for sensitivity and specificity(enrollment period)