HELIO Liver Test Performance Study in China (HEPATIC)

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.

Official Title
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Helio Liver Test Case-Controlled Performance Study in China (HEPATIC)

Conditions
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Hepatocellular Carcinoma and Liver Disease

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: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC diagnosed Stage 1 (both A and B)<br>200 stage 1 (A and B) HCC diagnosed patients | Diagnostic Test: Helio Liver Test<br>* A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.<br>|
| HCC diagnosed Stage 2<br>150 stage 2 HCC diagnosed patients | Diagnostic Test: Helio Liver Test<br>* A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.<br>|
| HCC diagnosed Stage 3<br>100 stage 3 HCC diagnosed patients | Diagnostic Test: Helio Liver Test<br>* A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.<br>|
| HCC diagnosed Stage 4<br>50 stage 4 HCC diagnosed patients | Diagnostic Test: Helio Liver Test<br>* A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.<br>|
| Control liver cancer surveillance subjects<br>500 patients total: 250 Subjects with liver cirrhosis, 250 subjects without liver cirrhosis | Diagnostic Test: Helio Liver Test<br>* A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate sensitivity and specificity of Helio Liver Test | 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. | enrollment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary subset analysis for sensitivity | The sensitivity of the Helio Liver Test will be calculated based on cancer stage | enrollment period | 
| secondary subset analysis for sensitivity and specificity | The sensitivity and specificity of the Helio Liver Test will be evaluated based upon the underlying cause of liver cirrhosis | enrollment period | 
| secondary subset for sensitivity and specificity by severity of liver cirrhosis | Sensitivity and specificity by severity of liver cirrhosis (Child-Pugh score) | enrollment period |