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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Hepatocellular carcinoma associated with cirrhosis

• Ages between 18 and 70 years

• Total tumour volume below 500 cm3

• Total number of tumour lesions below 10

• Maximum individual tumour diameter below 10 cm

Locations
Other Locations
Portugal
Centro Hepato-bilio-pancreático e de Transplantação do Hospital Curry Cabral
RECRUITING
Lisbon
Contact Information
Primary
Hugo Pinto-Marques, MD PhD
hugo.marques3@chlc.min-saude.pt
+351917302214
Backup
Sílvia Gomes-da-Silva, MD
silvia.silva@chlc.min-saude.pt
+351916876393
Time Frame
Start Date: 2021-03-25
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 40
Treatments
Experimental: liver transplant outside the Milan Criteria
patients with hepatocellular carcinoma, outside the Milan Criteria, that complied with the proposed HepatoPredictTool, submitted to liver transplant
Sponsors
Collaborators: Ophiomics - Precision Medicine
Leads: Centro Hospitalar de Lisboa Central

This content was sourced from clinicaltrials.gov