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).
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.
Study Type
OBSERVATIONAL
Enrollment
290
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).
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for early stage HCCs (Stage I and II)
performance evaluation (early stage, Stage I and II)
Time frame: 15 months
Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs
performance evaluation at all stages (I through IV)
Time frame: 15 months
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