Liver Transplant for Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
This research focuses on analysing data collected as part of your usual care. Currently, the eligibility of patients with hepatocellular carcinoma for liver transplantation is based on the calculation of scores. These scores mainly take into account the volume of the tumour measured by imaging, one or more blood markers and the patient's general condition.
However, these scores do not take into account:
* the concept of downstaging (i.e. the prior reduction of tumour volume through locoregional or systemic treatments, which subsequently allows access to LT), which is becoming increasingly widespread * the dynamics of hepatocellular carcinoma (tumour recurrence while waiting on the transplant list, administration of wait-and-see treatments) * certain anatomopathological parameters (such as the macro-trabecular subtype of HCC).
The aim of our study is to develop a new score incorporating these factors in order to identify patients with hepatocellular carcinoma who could truly benefit from a liver transplant.
To answer the question posed in the research, data will be collected from 402 people who received a liver transplant for hepatocellular carcinoma at three hospitals in the Paris region between 1 January 2018 and 31 December 2023, and from 160 people at two international hospitals in Canada and Belgium.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years).
Underwent LT for HCC between January 1, 2018 and December 31, 2023.
Disqualifiers
No evidence of HCC (imaging or histology).
LT performed for another intrahepatic tumor other than HCC.
The patient's objection to the use of their data.
Trial population
We will retrospectively include patients who underwent LT for HCC between 1 January 2018 and 31 December 2023 in the Paris, Montreal and Brussels centres. The derivation cohort will include patients from the AP-HP, while the validation cohort will include patients from the centres in Montreal and Brussels.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Failure of liver transplantation (LT)
Failure of LT is defined as the occurrence of one of the following events: (i) removal from the transplant waiting list, (ii) recurrence of HCC post-LT, or (iii) death.
Time frame
Up to 7 years after LTSecondary outcomes
1
Overall survival
Time frame
Up to 7 years after LT2
Recurrence-free survival
Time frame
Up to 7 years after LT3
Occurrence of acute cellular rejection
Time frame
Up to 7 years after LT4
Correlation of LT failure rate, overall survival and recurrence-free survival with biological, clinical, imaging and anatomopathological parameters (macro-trabecular subtype) at enrolment and on the day of LT
Time frame
Up to 7 years after LTLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
Erasme University Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: