Collects data to build predictive models for liver transplant waitlist patients
Collects health data from adults on the liver transplant waitlist to predict dropout risk.
Plain-language title generated from the registry record
Registry title: LEOPARD Training and Validation Data Collection Study
Key facts
- Where
- Ancona, Bari, Bologna, Genova, Milan, Modena, Naples, Padova, Palermo, Pisa, Roma, Rome, Torino, Udine, and Verona, ItalySee the 17 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06675604, who can take part
Where in Italy
- Universita Politecnica Delle MarcheAncona, ItalyTaking people
- AOU Policlinico di BariBari, ItalyTaking people
- Hepatobiliary Surgery and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di BolognaBologna, ItalyTaking people
- Ospedale Policlinico San MartinoGenova, ItalyTaking people
- Division of General Surgery & Abdominal Transplantation, Asst Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Hepato-Pancreato-Biliary Surgery and Liver Transplantation, Azienda Ospedaliero Universitaria Policlinico di ModenaModena, ItalyTaking people
- Azienda Ospedaliera Di Rilievo Nazionale A. CardarelliNaples, ItalyTaking people
- Azienda Ospedale Universita PadovaPadova, ItalyTaking people
- Gastroenterology department, Istituto Mediterraneo per i Trapianti Ismett IRCCSPalermo, ItalyTaking people
- Hepatobiliary Surgery and Liver Transplantation, Azienda Ospedaliero Universitaria Pisana (Via Paradisa)Pisa, ItalyTaking people
- Azienda Ospedaliero - Universitaria Policlinico Umberto I di RomaRoma, ItalyTaking people
- Hospital Tor Vergata RomaRoma, ItalyTaking people
- Azienda Ospedaliera San Camillo ForlaniniRome, ItalyTaking people
- Dipartimento di chirurgia generale e specialistica e dei trapianti, Università degli Studi di TorinoTorino, ItalyTaking people
- Università degli Studi di UdineUdine, ItalyTaking people
- Liver Transplant Unit, Surgery and Oncology, University of VeronaVerona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT06675604
- Record updated
- 29 July 2026
- Original description
Intro:Read full original descriptionShow less
Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates
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.
Inclusion: 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.).
Exclusion: 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.