Clinical trial · Observational
Retrospective Clinical Validation of HepatoPredict
Retrospective Clinical Validation of HepatoPredict, a Prognostic Tool for Hepatic Surgery Based on a Molecular Signature
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepato Cellular Carcinoma (HCC) | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
| Liver Resection | — | UNRESOLVED | — |
| Liver Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients with HCC, who underwent liver transplantation
- description
- Patients with early to intermediate HCC that underwent liver transplantation, with at least 5-year clinical follow-up.
- label
- Patients with HCC, who underwent liver resection
- description
- Patients with early to intermediate HCC that underwent liver resection, with at least 5-year clinical follow-up.
Primary outcomes (1)
- measure
- Recurrence-Free Survival (RFS)
- timeFrame
- Prior to 2019, until the begining of the study
- description
- 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).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * Age \< 18 years old. * Other non-HCC liver cancers patients. * Patients with tumor extra-hepatic spread at diagnosis.
References
Publications (3)
- BACKGROUNDAndrade R, Perez-Rojas J, da Silva SG, Miskinyte M, Quaresma MC, Frazao LP, Peixoto C, Cubells A, Montalva EM, Figueiredo A, Cipriano A, Goncalves-Reis M, Proenca D, Folgado A, Pereira-Leal JB, Oliveira RC, Pinto-Marques H, Tralhao JG, Berenguer M, Cardoso J. HepatoPredict Accurately Selects Hepatocellular Carcinoma Patients for Liver Transplantation Regardless of Tumor Heterogeneity. Cancers (Basel). 2025 Feb 2;17(3):500. doi: 10.3390/cancers17030500. PMID 39941867
- BACKGROUNDGoncalves-Reis M, Proenca D, Frazao LP, Neto JL, Silva S, Pinto-Marques H, Pereira-Leal JB, Cardoso J. Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation. Pract Lab Med. 2024 Feb 5;39:e00365. doi: 10.1016/j.plabm.2024.e00365. eCollection 2024 Mar. PMID 38371895
- BACKGROUNDPinto-Marques H, Cardoso J, Silva S, Neto JL, Goncalves-Reis M, Proenca D, Mesquita M, Manso A, Carapeta S, Sobral M, Figueiredo A, Rodrigues C, Milheiro A, Carvalho A, Perdigoto R, Barroso E, Pereira-Leal JB. A Gene Expression Signature to Select Hepatocellular Carcinoma Patients for Liver Transplantation. Ann Surg. 2022 Nov 1;276(5):868-874. doi: 10.1097/SLA.0000000000005637. Epub 2022 Aug 1. PMID 35916378