Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC

Study Overview
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Brief Summary
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This study will enroll patients with hepatocellular carcinoma being planned for TACE or other standard of care treatment and obtain blood samples pre and post TACE for biomarker identification using bead based X-aptamer library. No intervention is planned.

Detailed Description
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This is a prospective, non-blinded, multi-arm study. Patients at 18 - 70 years old with liver cancer will be enrolled. The approach is to identify novel proteomic biomarkers for HCC patients treated with Lipiodol TACE using beads-based X-aptamer library, then validate and create a biomarker panel that can be used to predict the outcome of HCC post-Lipiodol TACE treatment. Lipiodol TACE will be done as standard of care and the only thing done as research will be blood draws pre and post-TACE.

Official Title
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Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for Hepatocellular Carcinoma (HCC)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Lipiodol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent. Male or female aged 18-70years. Diagnosed with primary or metastatic liver cancer. Scheduled to undergo Lipoidal TACE, denovo ablation, or Yttrium-90 (Y90) radioembolization as part of standard of care. Exclusion Criteria: Subjects who have received chemotherapy, radiation or surgery for HCC.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 for Lipiodol TACE, denovo ablation, or Y90 radioembolization<br>These patients will receive standard of care Lipiodol TACE, denovo ablation, or Y90 radioembolization treatment. No research intervention is planned. | Drug: Lipiodol<br>* Lipiodol TACE procedure<br>|
| Healthy controls<br>Healthy controls from public database | |
| HCC patients<br>HCC patients will be used for biomarker validation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients | X-aptamer identified biomarker to predictability for tumor response rate after treatment with Lipoidol TACE compared to standard of care biomarkers-AFP. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients. | X-aptamer identified biomarker to predict overall survival after treatment with Lipoidol TACE . | 2 years |