Fact CheckerSign in

NCT04499833Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Jun 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
31 Jul 2020
Start date
25 Mar 2021
Primary completion date
30 Oct 2028
Lead sponsor
Centro Hospitalar de Lisboa Central
NCT number
NCT04499833

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 25 Mar 2021 to the primary completion date, 30 Oct 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • eligible under the "Milan Criteria"

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Hepato-bilio-pancreático e de Transplantação do Hospital Curry Cabral
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.