Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT04499833

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

Led by Centro Hospitalar de Lisboa Central · Updated on 2022-06-06

40

Participants Needed

1

Research Sites

457 weeks

Total Duration

On this page

Sponsors

C

Centro Hospitalar de Lisboa Central

Lead Sponsor

O

Ophiomics - Precision Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of hepatocellular carcinoma associated with cirrhosis
  • Age between 18 and 70 years
  • Total tumor volume below 500 cm3
  • Total number of tumor lesions below 10
  • Maximum individual tumor diameter below 10 cm
Not Eligible

You will not qualify if you...

  • Eligible for liver transplant under the Milan Criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Lisbon, Portugal, 1069-166

Actively Recruiting

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Research Team

H

Hugo Pinto-Marques, MD PhD

CONTACT

S

Sílvia Gomes-da-Silva, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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