Evaluation of molecular biomarkers for hepatocellular carcinoma (HCC) therapy

This is a single centre, prospective, exploratory and observational study of adults (aged 18 and over) who are undergoing therapy for hepatocellular carcinoma (HCC). Study question 1: Following HCC therapy, how do biomarkers change over time? Can this help inform HCC prognosis and predict early recurrence? Suitable patients will be identified during the HCC multi-disciplinary meeting and will be approached by an investigator via face to face, telehealth or telephone contact. This may be done during or outside of a scheduled HCC clinic. Time points for blood tests include baseline (just prior to therapy), immediately after therapy then every 3 months, for up to 2 years. An additional time point for blood sample collection will be added at approximately week 4-6 for patients who receive routine follow imaging at the time and also for patients receiving systemic therapy. Laboratory tests such as digital droplet PCR will be utilized to determine patient specific mutations. Novel biomarkers such as serum markers (Alfa-fetoprotein, Des-gamma-carboxy prothrombin), somatic mutations (TERT promoter), methylation markers may be tested. Study question 2: In the subset of patients with HCC referred for consideration of liver transplant assessment, how do their biomarkers change over time prior to transplantation? We aim to describe biomarker kinetics in patients with HCC following referral for liver transplant assessment. These patients may be recruited regardless of previous therapy. In this part of the study, we aim to collect blood samples every three months, prior to liver transplantation. This will be performed during their routine imaging as part of standard of care. Following liver transplantation, these patients will cross over into study question 1.