Informations générales (source: ClinicalTrials.gov)
Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates
Observational
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2025
février 2029
16 septembre 2025
Intro:
The present clinical research protocol is part of the LEOPARD European project (Grant n°
101080964 Horizon Europe) which aims to design and validate new predictive models of
mortality among liver transplantation (LT) candidates. MELD based-liver graft allocation
systems have become increasingly inaccurate over the last decade to predict
mortality/dropout of liver transplantation (LT) candidates on the waitlist (WL). Wide
disparities in mortality/dropout on the WL also exist across European countries, ranging
from 5 to 30% according to transplantation indications and countries. In this setting,
the European Commission- Horizon Europe funded-LEOPARD project intends to design new, 2nd
generation, AI-machine learning-based predictive models of delisting in LT candidates, to
better serve on time patients with the highest risk of dropout on the WL and to improve
equity of access to LT across Europe.
Hypothesis/Objective:
The scientific justification of the LEOPARD TVDCS is therefore to collect a large set of
data in liver transplantation candidates listed in Europe a) to design and b) to validate
LEOPARD 2nd generation AI-based predictive models of mortality/dropout The primary
objective is to develop new predictive models of mortality/drop out on the waitlist in
patients with decompensated cirrhosis, or other end-stage chronic liver diseases, and in
patients listed for Hepato-cellular carcinoma (HCC).
Method:
Longitudinal multicenter prospective health care data collection cohort study in 2 sets :
Training/development set : Prospective health care data collection in 3,000 patients
listed in 50 centres across 7 countries and Validation set: Prospective health care data
collection in 1,500 subsequent patients listed in the same 50 centres.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:41:10 | Contacter | |||
| AP-HP - Hôpital Beaujon | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Paul Brousse | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Beaujon, Department of Hepatology - 92110 - Clichy - France | Olivier Roux, MD | 13/12/2025 07:41:08 | Contact (sur clinicalTrials) | ||
| CHU Paul Brousse, Department of Hepatology - 94800 - Villejuif - France | Audrey Coilly, MD-PHD | 13/12/2025 07:41:08 | Contact (sur clinicalTrials) | ||
| Hospital Henri Mondor, Department of Hepatology - 94010 - Créteil - France | Christophe Duvoux, MD-PHD | 13/12/2025 07:41:08 | Contact (sur clinicalTrials) | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU Huriez Lille, Department of Hepatology - 59000 - Lille - France | Sébastien Dharancy, MD-PHD | Contact (sur clinicalTrials) | |||
| CHRU Montpellier Saint Eloi, Department of Hepatology - 34295 - Montpellier - France | Jose Ursic-Bedoya, MD-PHD | Contact (sur clinicalTrials) | |||
| CHRU Strasbourg, Chirurgie Hepato-bilio-pancreatique et transplantation hepatique Department - 67000 - Strasbourg - France | Baptiste Michard, MD | Contact (sur clinicalTrials) | |||
| CHU Bordeaux Haut Levêque, Department of Hepatology - 33604 - Pessac - France | Faiza Chermak, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon, Department of Hepatology - 21069 - Dijon - France | Marianne Latournerie, MD | Contact (sur clinicalTrials) | |||
| CHU Jean Minjoz Besançon, Department of Hepatology - 25000 - Besançon - France | Delphine Weil Verhoeven, MD | Contact (sur clinicalTrials) | |||
| CHU La Pitié Salpêtrière, Department of Hepatology - 75013 - Paris - France | Alessandra Mazzola, MD | Contact (sur clinicalTrials) | |||
| CHU La Timone AP-HM, Department of Hepatology - 13005 - Marseille - France | Clara Dassetto, MD | Contact (sur clinicalTrials) | |||
| CHU L'Archet Nice, Department of Hepatology - 06000 - Nice - France | Rodolphe Anty, MD-PHD | Contact (sur clinicalTrials) | |||
| CHU Lyon Croix Rousse, Department of Hepatology - 69004 - Lyon - France | Teresa Antonini, MD | Contact (sur clinicalTrials) | |||
| CHU Pontchaillou Rennes, Department of Hepatology - 35033 - Rennes - France | Baptiste Giguet, MD | Contact (sur clinicalTrials) | |||
| CHU Purpan Toulouse, Department of Hepatology - 31059 - Toulouse - France | Marie-Angèle Robic, MD | Contact (sur clinicalTrials) | |||
| CHU Trousseau Tours, Department of Hepatology - 37170 - Chambray-lès-Tours - France | Laure Elkrief, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult [age 18;70] patients listed for:
- decompensated cirrhosis as primary diagnosis, irrespective of liver disease
etiology (subset 1) OR
- other chronic end-stage liver diseases requiring LT, to be listed under a
MELD-based allocation system (examples: primary biliary cholangitis, primary
sclerosing cholangitis etc...) (subset 2) OR
- HCC* as primary diagnosis, whatever the etiology of the underlying liver
disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on
Barcelona/EASL criteria or histologically proven. HCC meeting or not Milan
criteria, as per center practice.)
- Patients registered on national waiting lists under the MELD offering schemes,
regardless of extra MELD points and MELD exceptions are affected or not.
- Patient (or trusted person, family member or close relation, if the patient is
unable to be informed) who has been informed and did not express opposition to data
collection
(*Of note, enrolment of patients with T1 tumors (1 single tumor < 2 cm diameter) not
amenable to loco-regional therapies because of decompensation, and prioritized under the
MELD system, will be allowed in Subset 1.)
- Adult [age 18;70] patients listed for:
- decompensated cirrhosis as primary diagnosis, irrespective of liver disease
etiology (subset 1) OR
- other chronic end-stage liver diseases requiring LT, to be listed under a
MELD-based allocation system (examples: primary biliary cholangitis, primary
sclerosing cholangitis etc...) (subset 2) OR
- HCC* as primary diagnosis, whatever the etiology of the underlying liver
disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on
Barcelona/EASL criteria or histologically proven. HCC meeting or not Milan
criteria, as per center practice.)
- Patients registered on national waiting lists under the MELD offering schemes,
regardless of extra MELD points and MELD exceptions are affected or not.
- Patient (or trusted person, family member or close relation, if the patient is
unable to be informed) who has been informed and did not express opposition to data
collection
(*Of note, enrolment of patients with T1 tumors (1 single tumor < 2 cm diameter) not
amenable to loco-regional therapies because of decompensation, and prioritized under the
MELD system, will be allowed in Subset 1.)
- Tumor vascular invasion (portal or hepatic veins) evidenced by imaging at pre
transplantation work-up, including portal vein thrombosis stage 1
- Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional
imaging (18 FDG PET CT/MRI) or histologically proven
- Patients who are under safeguard of justice or tutorship or curatorship
- Patient on AME (state medical aid)
- Participation to LEOPARD PVC 1 study of WP2