Under construction – not a live service
Sign in
Taking people in ItalyNo phase

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.

Key facts

Who runs it
Assistance Publique - Hôpitaux de Paris
Where
Ancona, Bari, Bologna, Genova, Milan, Modena, Naples, Padova, Palermo, Pisa, Roma, Rome, Torino, Udine, and Verona, ItalySee the 17 sitesAlso in 6 other countries, 36 sites
Trial code
Registry title
LEOPARD Training and Validation Data Collection Study
Status
Recruiting
People taking part
4,500 people, planned
Started
4 Feb 2025
Expected to end
4 Feb 2029
Type of study
Observational, 3 groups
Record updated
29 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 70 who are on the waiting list for a liver transplant because of decompensated cirrhosis, another end-stage chronic liver disease, or liver cancer (HCC).

Age
18 to 70 years
Sex
All sexes
Disease stage
Listed for a liver transplant for decompensated cirrhosis, for another chronic end-stage liver disease such as primary biliary cholangitis or primary sclerosing cholangitis, or for HCC (diagnosed by Barcelona/EASL criteria or by tissue test).

Main reasons for not taking part

  • Tumor growing into the portal or hepatic veins on imaging, including portal vein thrombosis stage 1
  • HCC that has spread outside the liver
  • Under legal protection (justice, tutorship or curatorship)
  • On AME (state medical aid)
  • Taking part in the LEOPARD PVC 1 study of WP2

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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.)

Who cannot take part

  • 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

Check if you might fit

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?

Where in Italy

Also in 6 other countries, 36 sites

  • Universita Politecnica Delle MarcheAncona, ItalyContact: Marco Vivarelli, MDTaking people
  • AOU Policlinico di BariBari, ItalyContact: Francesco Tandoi, MD-PHDTaking people
  • Hepatobiliary Surgery and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di BolognaBologna, ItalyContact: Matteo Cescon, MDTaking people
  • Ospedale Policlinico San MartinoGenova, ItalyContact: Paolo Montanelli, MDTaking people
  • Division of General Surgery & Abdominal Transplantation, Asst Grande Ospedale Metropolitano NiguardaMilan, ItalyContact: Andrea Lauterio, MDTaking people
  • Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyContact: Marco Bongini, MDTaking people
  • Hepato-Pancreato-Biliary Surgery and Liver Transplantation, Azienda Ospedaliero Universitaria Policlinico di ModenaModena, ItalyContact: Fabrizio Di Benedetto, MD-PHDTaking people
  • Azienda Ospedaliera Di Rilievo Nazionale A. CardarelliNaples, ItalyContact: Alfonso Galeota Lanza, MDTaking people
  • Azienda Ospedale Universita PadovaPadova, ItalyContact: Umberto Cillo, MD-PHDTaking people
  • Gastroenterology department, Istituto Mediterraneo per i Trapianti Ismett IRCCSPalermo, ItalyContact: Salvo Gruttadauria, MD-PHDTaking people
  • Hepatobiliary Surgery and Liver Transplantation, Azienda Ospedaliero Universitaria Pisana (Via Paradisa)Pisa, ItalyContact: Davide Ghinolfi, MD-PHDTaking people
  • Azienda Ospedaliero - Universitaria Policlinico Umberto I di RomaRoma, ItalyContact: Fabio Melandro, MDTaking people
  • Hospital Tor Vergata RomaRoma, ItalyContact: Tommaso Maria Manzia, MDTaking people
  • Azienda Ospedaliera San Camillo ForlaniniRome, ItalyContact: Giuseppe Maria Ettorre, MDTaking people
  • Dipartimento di chirurgia generale e specialistica e dei trapianti, Università degli Studi di TorinoTorino, ItalyContact: Torino Romagnoli, MD-PHDTaking people
  • Università degli Studi di UdineUdine, ItalyContact: Umberto Baccarani, MDTaking people
  • Liver Transplant Unit, Surgery and Oncology, University of VeronaVerona, ItalyContact: Amedeo Carraro, MDTaking people

About the trial

What the trial wants to find out

Intro:

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Subset 1

    Decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology

  • Subset 2

    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 3

    Hepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates
Plain-language title
Collects data to build predictive models for liver transplant waitlist patientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06675604, who can take part
Record updated
29 July 2026