Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Specimen Collection for Multi-Analyte Blood-Test for Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma by AJCC Stage

Intervention / Treatment
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* Diagnostic Test: Helio Liver Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years and Older (Adult, Older Adult) Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC Subjects<br>All subjects will be recently diagnosed with hepatocellular carcinoma as defined by at least one of the following criteria: Subject has a ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance by MRI and/or CT. Subject has a lesion of any size indicated to be HCC due to capsule appearance by 4 phase CT scan and/or multiphase contrast enhanced MRI. Subjects with a suspicious lesion of less than 2 cm must have HCC confirmed by both MRI and CT. 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). | Diagnostic Test: Helio Liver Test<br>* 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).<br>|
| Surveillance Subjects<br>At-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC. | Diagnostic Test: Helio Liver Test<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 15 months | 
| Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs | performance evaluation at all stages (I through IV) | 15 months |