Novel Biomarker Assay for Biomarker Assay for HCC Detection

Study Overview
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Brief Summary
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The primary purpose of this study is to assess the performance feasibility of Genetron's novel HCC liquid biopsy biomarkers assay for early detection. Piedmont Transplant Institute will provide a longitudinally collected blood sample from all HCC cases (mixture of early and advanced stage HCC) and cirrhosis control to Genetron Health after obtaining informed consent.

Detailed Description
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HCC is a leading cause of cancer-related deaths in the US. Early detection is crucial to improve the outcome of HCC. HCC surveillance is recommended for early detection of HCC in patients with cirrhosis. However, current HCC surveillance tests, such as liver ultrasound and AFP have relatively low accuracy for the detection of early-stage HCC. Genetron Health recently published on novel liquid biopsy biomarker for detection of HCC in China. The biomarker showed excellent performance for the detection of HCC among the at-risk population, most of whom had HBV infection. It is crucial to validate the performance of this novel biomarker in an independent population of patients with different etiology of liver disease outside of China. As this novel biomarker is useful in the detection of small HCC, it may also serve as an excellent biomarker for assessment of treatment response and monitoring of recurrence. The primary purpose of this study is to assess the performance feasibility of Genetron's novel HCC liquid biopsy biomarkers assay for early detection. Piedmont Transplant Institute will provide a longitudinally collected blood sample from all HCC cases (mixture of early and advanced stage HCC) and cirrhosis control to Genetron Health after obtaining informed consent. Genetron Health will analyze the blood sample and provide data to the PI, for internal review purposes. Should the initial pilot study be successful, the parties will have a discussion to expand the number of cases and control samples and consider conducting a multicenter prospective study.

Official Title
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Novel Biomarker Assay for HCC Detection and Monitoring Piedmont Transplant Institute and Genetron Health, Inc.

Conditions
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Hepato-cellular Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with HCC (based on histology or radiology according to AASLD guideline) or liver cirrhosis (based on the clinical history of hepatic encephalopathy, thrombocytopenia, radiologic features of the nodular liver, features of portal hypertension such as ascites, splenomegaly, or MR elastogram or fibroscan showing result consistent with cirrhosis) Willing and able to provide informed consent to participate in this study Exclusion Criteria: Unable to provide blood samples Age less than 18 years of age Patient who have active cancers (excluding HCC) in the past five years, except for nonmelanoma skin cancer

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<br>HCC positive | |
| Non HCC<br>HCC negative | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCC screening positive | Data will suggest the probability of HCC | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC Screening