Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

Detailed Description
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Subjects with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing HCC surveillance will be enrolled and have blood samples collected. Subjects undergoing HCC surveillance will be followed for up to 6 months. Another blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.

Official Title
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2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma Surveillance, Hepatocellular Carcinoma

Intervention / Treatment
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* Other: Blood Sample Collection
* Other: Blood Sample Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Subjects: Subject is 18 years of age or older Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of data, including personal health data, to the study investigator and sponsor HCC Subjects: 1. Subject has a recent (within 6 months of enrollment) untreated clinically diagnosed hepatocellular carcinoma as defined by ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC. Control Subjects: Non-cancer subject undergoing routine imaging surveillance for HCC Definitive lack of HCC within 3 months prior to enrollment as defined by negative imaging, for HCC. Control Group 1 - negative by ultrasound Control Group 2 - negative by CT or MRI Exclusion Criteria: Known cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers). Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC. Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC). IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection. Less than 7 days between biopsy (other than FNA) of target pathology and blood collection. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC Surveillance<br>Approximately 1400 HCC surveillance subjects (controls) will be enrolled. | Other: Blood Sample Collection<br>* Surveillance subjects will have a blood sample collected and will be followed for up to 6 months. A second blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.<br>|
| HCC<br>Approximately 700 subjects with untreated clinically diagnosed HCC will be enrolled. | Other: Blood Sample Collection<br>* HCC subjects will have one blood sample collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker Identification | Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with HCC compared to those without (but are at risk of developing the disease so are under surveillance) | 1 year |