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LEOPARD Training and Validation Data Collection Study
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Official title: Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
4500
Start Date
2025-02-04
Completion Date
2029-02-04
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Locations (53)
Universitätsklinik für Allgemeinchirurgie, Klinische Abteilung für Transplantation
Vienna, Austria
Hôpital Erasme Université Libre de Bruxelles
Brussels, Belgium
Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent
Ghent, Belgium
Cliniques Universitaires Saint-Luc (UCLouvain)
Leuven, Belgium
UZ Leuven
Leuven, Belgium
CHU Liège
Liège, Belgium
CHU Jean Minjoz Besançon, Department of Hepatology
Besançon, France
CHU Trousseau Tours, Department of Hepatology
Chambray-lès-Tours, France
CHU Beaujon, Department of Hepatology
Clichy, France
Hospital Henri Mondor, Department of Hepatology
Créteil, France
CHU Dijon, Department of Hepatology
Dijon, France
CHRU Huriez Lille, Department of Hepatology
Lille, France
CHU Lyon Croix Rousse, Department of Hepatology
Lyon, France
CHU La Timone AP-HM, Department of Hepatology
Marseille, France
CHRU Montpellier Saint Eloi, Department of Hepatology
Montpellier, France
CHU L'Archet Nice, Department of Hepatology
Nice, France
CHU La Pitié Salpêtrière, Department of Hepatology
Paris, France
CHU Bordeaux Haut Levêque, Department of Hepatology
Pessac, France
CHU Pontchaillou Rennes, Department of Hepatology
Rennes, France
CHRU Strasbourg, Chirurgie Hepato-bilio-pancreatique et transplantation hepatique Department
Strasbourg, France
CHU Purpan Toulouse, Department of Hepatology
Toulouse, France
CHU Paul Brousse, Department of Hepatology
Villejuif, France
Department for General, Visceral, Pediatric and Transplant Surgery, Universitätsklinikum Aachen
Aachen, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Gastroenterology, Hepatology, Infectious Diseases and Endocrinology (GHIE) Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Jena
Jena, Germany
Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine
Kiel, Germany
Universität Leipzig
Leipzig, Germany
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Münster
Münster, Germany
Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Università Politecnica delle Marche
Ancona, Italy
Aou Policlinico di Bari
Bari, Italy
Hepatobiliary Surgery and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
Ospedale Policlinico San Martino
Genova, Italy
Division of General Surgery & Abdominal Transplantation, Asst Grande Ospedale Metropolitano Niguarda
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Hepato-Pancreato-Biliary Surgery and Liver Transplantation, Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Italy
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Naples, Italy
Azienda Ospedale - Università Padova
Padova, Italy
Gastroenterology department, Istituto Mediterraneo per i Trapianti Ismett IRCCS
Palermo, Italy
Hepatobiliary Surgery and Liver Transplantation, Azienda Ospedaliero Universitaria Pisana (Via Paradisa)
Pisa, Italy
Azienda Ospedaliero Universitaria Policlinico Umberto I di Roma
Roma, Italy
Hospital tor Vergata Roma
Roma, Italy
Azienda Ospedaliera San Camillo-Forlanini
Rome, Italy
Dipartimento di chirurgia generale e specialistica e dei trapianti, Università degli Studi di Torino
Torino, Italy
Università Degli Studi di Udine
Udine, Italy
Liver Transplant Unit, Surgery and Oncology, University of Verona
Verona, Italy
Center for Liver Tumors Leiden of the Leiden University Medical Center (LUMC)
Leiden, Netherlands
Gastroenterology and Hepatology, Rotterdam Erasmus Medical Center
Rotterdam, Netherlands
Department of General, Visceral and Transplantation Surgery, Hospital Universitario Virgen de La Arrixaca
Murcia, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital General Universitari València
Valencia, Spain