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| Name | Class |
|---|---|
| Laboratory for Advanced Medicine, Guangzhou | UNKNOWN |
| Helio Health Inc., Irvine, CA | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC Subjects | All subjects will be recently diagnosed with hepatocellular carcinoma as defined by at least one of the following criteria:
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| Surveillance Subjects | At-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helio Liver Test | Diagnostic Test | 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have been clinically diagnosed with HCC, or are negative for HCC after regular surveillance, or have been clinically diagnosed with non-HCC cancers will be enrolled. Approximately 500 subjects will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| RIchard Van Etten, MD, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510060 | China | ||
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Serum and Plasma samples
| The Third Affiliated Hospital of Sun Yat-sen University |
| Guangzhou |
| Guangdong |
| 510060 |
| China |