Blood Sample Collection for Experimental Blood Test to Track Liver Cancer

Study Overview
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Brief Summary
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This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers guide treatment for other patients in the future.

Official Title
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Circulating MicroRNA Levels as a Predictor of Successful Bridging or Down-Staging Loco-Regional Therapy (LRT) to Liver Transplantation for Patients With Hepatocellular Carcinoma (HCC)

Conditions
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Hepatocellular Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria) Felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy Exclusion Criteria: Either active or recent solid organ cancer other than hepatocellur carcinoma (HCC) within the last 5 years, unless determined by transplant hepatology team not to represent contra-indication to liver transplantation Contra-indication to LRT (as assessed by interventional radiologist, for example severe thrombocytopenia, severe vascular disease precluding access, etc) History of prior liver transplantation Active or prior systemic therapy for HCC

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Clinical Status - Liver Transplant | Undergoing liver transplant | At study completion, up to 12 months | 
| Patient Clinical Status - Death | Will assess the following: death | At study completion, up to 12 months | 
| Patient Clinical Status - Candidacy | No longer candidate for transplantation for reasons other than tumor progression | At study completion, up to 12 months | 
| Patient Clinical Status | No longer candidate for transplantation due to tumor progression despite loco-regional therapy efforts | At study completion, up to 12 months | 
| Incidence of Wait List Drop Off | Will be estimated and presented with a Clopper-Pearson exact binomial confidence interval | At study completion, up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Wait List Drop Off | Cox proportinal hazards modeling will be used to investigate the associations of each micro ribonucleic acid (miRNO) with time to wait list drop off | Up to 12 months | 
| Clinical Status of the subset of patients successfully reaching liver transplant | Logistic regression modeling will be used to investigate the correlation of each miRNA with clincial status (alive without recurrence vs. recurrence or death) within one year of transplant will be cinducted in the subset of those undergoing transplant. The p-values will be adjusted for false discovery rate inflation by the methods of Benjamni & Hochberg (1995) for both secondary analyses, respectively | At 1 year after transplantation |