Hepatocellular Carcinoma
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Clinical Status - Death | At study completion, up to 12 months | Will assess the following: death |
| Patient Clinical Status | At study completion, up to 12 months | No longer candidate for transplantation due to tumor progression despite loco-regional therapy efforts |
| Incidence of Wait List Drop Off | At study completion, up to 12 months | Will be estimated and presented with a Clopper-Pearson exact binomial confidence interval |
| Patient Clinical Status - Liver Transplant | At study completion, up to 12 months | Undergoing liver transplant |
| Patient Clinical Status - Candidacy | At study completion, up to 12 months | No longer candidate for transplantation for reasons other than tumor progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Status of the subset of patients successfully reaching liver transplant | At 1 year after transplantation | 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 |
| Time to Wait List Drop Off | Up to 12 months | Cox proportinal hazards modeling will be used to investigate the associations of each micro ribonucleic acid (miRNO) with time to wait list drop off |
Countries
United States
Outcome results
None listed