About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old.

Patients with HCC that underwent transplantation, with at least 5 years follow-up.

Patients with HCC that underwent surgical resection, with at least 5 years follow-up.

Completed informed consent process (for patient candidates that are still alive).

Disqualifiers

Age < 18 years old.

Other non-HCC liver cancers patients.

Patients with tumor extra-hepatic spread at diagnosis.

Trial population

Patients with early to intermediate HCC that underwent liver transplantation or liver resection, with at least 5-year clinical follow-up, that have FFPE surgical fragments/explants still available.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants

are grouped into 2 trial groups

Group A: Patients with HCC, who underwent liver transplantation

Group B: Patients with HCC, who underwent liver resection

Trial outcomes

Primary outcomes

1

Recurrence-Free Survival (RFS)

This study aims to retrospectively evaluate the predictive power of HepatoPredict (positive and negative) to prognosticate patient's outcome and recurrence, after surgical treatment of Hepatocellular carcinoma (liver transplantation or liver resection). To this aim two outcome measure will be used: recurrence free survival (RFS) and overall survival (OS).

Time frame

Prior to 2019, until the begining of the study

Secondary outcomes

1

Overall Survival (OS)