RecruitingNot ApplicableNCT04499833

HepatoPredict Prognostic Tool for the Decision of Liver Transplant in Hepatocellular Carcinoma

Evaluation of the HepatoPredict Prognostic Tool in the Decision of Liver Transplant in Hepatocellular Carcinoma


Sponsor

Centro Hospitalar de Lisboa Central

Enrollment

40 participants

Start Date

Mar 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive biological behaviour. To more accurately select candidates for liver transplant, the inclusion of criteria that could predict the behaviour and aggressiveness of tumours, such as molecular markers, might be useful. The investigators propose the use of a new algorithm (HepatoPredict Prognostic Tool), that combine clinical and molecular criteria that address the biology of tumours, in a single centre prospective, intervention study. Data from the "HepatoPredict genomic signature" are added to the clinical and imagiology algorithm. Based on this tool, patients outside the usual eligibility criteria for liver transplant will be proposed for this treatment. These patients will be transplanted with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy, not competing with patients on the waiting list. Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening. Survival and disease-free-survival rates will be compared with those obtained by the usual management of patients included and excluded by Milan Criteria.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a new scoring tool called HepatoPredict to help doctors decide who should receive a liver transplant among patients with liver cancer (hepatocellular carcinoma) that developed on a background of cirrhosis (scarring of the liver). The tool aims to better predict which patients will benefit most from transplant. **You may be eligible if...** - You have liver cancer (hepatocellular carcinoma) along with liver cirrhosis - You are between 18 and 70 years old - Your total tumor volume is less than 500 cubic centimeters - You have fewer than 10 tumor spots - Your largest individual tumor is less than 10 cm across **You may NOT be eligible if...** - You already meet the standard "Milan Criteria" used to qualify for transplant (this study focuses on patients who fall outside those criteria) - You have other serious health conditions preventing transplant consideration Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREliver transplant

liver transplant


Locations(1)

Centro Hepato-bilio-pancreático e de Transplantação do Hospital Curry Cabral

Lisbon, Portugal

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NCT04499833


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