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RECRUITING
NCT06675604

LEOPARD Training and Validation Data Collection Study

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

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