Retrospective Clinical Validation of HepatoPredict

HepatoPredict is an innovative prognostic tool to support hepatologists, hepatobiliary surgeons and multidisciplinary teams in deciding on the best therapeutical approach for a patient with Hepatocellular Carcinoma, the most common type of primary liver cancer. HepatoPredict is a laboratory test that analyses a molecular signature from a small tumour sample and combines this information with details from imaging tests, such as the number of nodules and their size. Using a computational model, HepatoPredict determines whether a patient is likely to remain disease-free after hepatic surgery (good prognosis) or if there is a higher chance of the tumour returning (bad prognosis). Current selection criteria to assess the eligibility of patients with Hepatocellular Carcinoma for liver transplantation present several problems, including: 1. selection of patients that will not benefit from a transplant. This could be due to recurrence of cancer or early death from another cause. 2. exclusion of patients who could benefit from a liver transplant but are currently not eligible; 3. increased tumor recurrence rates. Thus, improved tools that predict the likelihood of cancer coming back are needed to better assess if a patient will benefit from hepatic surgery. This will allow better use of organs, waiting list times, and improve ways of identifying the most appropriate treatments for individual patients. HepatoPredict accurately selects patients for hepatic surgery, outperforming conventional clinical criteria. In previous retrospective studies, HepatoPredict predicted successful surgery outcomes in patients who were not eligible by currently used criteria. This study aims to retrospectively validate the prognostic tool HepatoPredict in assessing how well a patient with Hepatocellular Carcinoma performed considering recurrence-free survival (no cancer recurrence) and overall survival after 5 years follow-up after liver surgery or liver transplantation.

NCT Number	NCT06894524
Lead Sponsor	Ophiomics Collaborators: University Hospital Birmingham NHS Foundation Trust
Conditions	Hepato Cellular Carcinoma (HCC), Liver Resection, Liver Transplantation
Enrollment	200 participants
Start Date	2025-03
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-03-25