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Decompensated Liver CirrhosisLEOPARD TVDCSNCT06675604

LEOPARD Training and Validation Data Collection Study

An observational study of Decompensated Liver Cirrhosis and Primary Biliary Cholangitis, run by Assistance Publique - Hôpitaux de Paris at 53 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
How many people
4,500 participants
Where
53 sitesin 7 countries
Study dates
4 Feb 2025to 4 Feb 2029
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults patients listed for : * Decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset 1) * 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) * Hepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3)

Who may be able to join

  • 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 join

  • 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

Trial locations and contacts

53 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Christophe DUVOUX, MD-PHD contact

01 49 81 23 25 ext. +33

christophe.duvoux@aphp.fr

Nihel BERREBEH, Project Manager contact

01 40 27 46 20 ext. +33

nihel.berrebeh@aphp.fr

53 sites in 7 countries

Italy17 sites, 17 recruiting

  • Università Politecnica delle Marche

    Ancona

    Marco Vivarelli, MD

    Recruiting

  • Aou Policlinico di Bari

    Bari

    Francesco Tandoi, MD-PHD

    Recruiting

  • Hepatobiliary Surgery and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna

    Matteo Cescon, MD

    Recruiting

  • Ospedale Policlinico San Martino

    Genova

    Paolo Montanelli, MD

    Recruiting

  • Division of General Surgery & Abdominal Transplantation, Asst Grande Ospedale Metropolitano Niguarda

    Milan

    Andrea Lauterio, MD

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

    Marco Bongini, MD

    Recruiting

  • Hepato-Pancreato-Biliary Surgery and Liver Transplantation, Azienda Ospedaliero Universitaria Policlinico di Modena

    Modena

    Fabrizio Di Benedetto, MD-PHD

    Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

    Naples

    Alfonso Galeota Lanza, MD

    Recruiting

  • Azienda Ospedale - Università Padova

    Padova

    Umberto Cillo, MD-PHD

    Recruiting

  • Gastroenterology department, Istituto Mediterraneo per i Trapianti Ismett IRCCS

    Palermo

    Salvo Gruttadauria, MD-PHD

    Recruiting

  • Hepatobiliary Surgery and Liver Transplantation, Azienda Ospedaliero Universitaria Pisana (Via Paradisa)

    Pisa

    Davide Ghinolfi, MD-PHD

    Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Umberto I di Roma

    Roma

    Fabio Melandro, MD

    Recruiting

  • Hospital tor Vergata Roma

    Roma

    Tommaso Maria Manzia, MD

    Recruiting

  • Azienda Ospedaliera San Camillo-Forlanini

    Rome

    Giuseppe Maria Ettorre, MD

    Recruiting

  • Dipartimento di chirurgia generale e specialistica e dei trapianti, Università degli Studi di Torino

    Torino

    Torino Romagnoli, MD-PHD

    Recruiting

  • Università Degli Studi di Udine

    Udine

    Umberto Baccarani, MD

    Recruiting

  • Liver Transplant Unit, Surgery and Oncology, University of Verona

    Verona

    Amedeo Carraro, MD

    Recruiting

Other trials in Italy

France16 sites, 16 recruiting

  • CHU Jean Minjoz Besançon, Department of Hepatology

    Besançon, 25000

    Delphine Weil Verhoeven, MD, 03 81 66 87 54 ext. +33, dweil@chu-besancon.fr

    Recruiting

  • CHU Trousseau Tours, Department of Hepatology

    Chambray-lès-Tours, 37170

    Laure Elkrief, MD, 02 47 47 59 37 ext. +33, l.elkrief@chu-tours.fr

    Recruiting

  • CHU Beaujon, Department of Hepatology

    Clichy, 92110

    Olivier Roux, MD, 01 40 87 55 22 ext. +33, olivier.roux@aphp.fr

    Recruiting

  • Hospital Henri Mondor, Department of Hepatology

    Créteil, 94010

    Christophe Duvoux, MD-PHD, 01 49 81 23 25 ext. +33, christophe.duvoux@aphp.fr

    Recruiting

  • CHU Dijon, Department of Hepatology

    Dijon, 21069

    Marianne Latournerie, MD, 03 80 29 37 50 ext. +33, marianne.latournerie@chu-dijon.fr

    Recruiting

  • CHRU Huriez Lille, Department of Hepatology

    Lille, 59000

    Sébastien Dharancy, MD-PHD, 03 20 44 55 97 ext. +33, Sebastien.DHARANCY@chru-lille.fr

    Recruiting

  • CHU Lyon Croix Rousse, Department of Hepatology

    Lyon, 69004

    Teresa Antonini, MD, 04 26 73 28 88 ext. +33, teresa.antonini@chu-lyon.fr

    Recruiting

  • CHU La Timone AP-HM, Department of Hepatology

    Marseille, 13005

    Clara Dassetto, MD, 04 91 38 00 00 ext. +33, Clara.DASSETTO@ap-hm.fr

    Recruiting

  • CHRU Montpellier Saint Eloi, Department of Hepatology

    Montpellier, 34295

    Jose Ursic-Bedoya, MD-PHD, 04 67 33 67 33 ext. +33, jose.ursicbedoya@chu-montpellier.fr

    Recruiting

  • CHU L'Archet Nice, Department of Hepatology

    Nice, 06000

    Rodolphe Anty, MD-PHD, 04.92.03.66.00 ext. +33, anty.r@chu-nice.fr

    Recruiting

  • CHU La Pitié Salpêtrière, Department of Hepatology

    Paris, 75013

    Alessandra Mazzola, MD, 01 42 17 56 88 ext. +33, alessandra.mazzola2@aphp.fr

    Recruiting

  • CHU Bordeaux Haut Levêque, Department of Hepatology

    Pessac, 33604

    Faiza Chermak, MD, 05 57 65 64 39 f ext. +33, faiza.chermak@chu-bordeaux.fr

    Recruiting

  • CHU Pontchaillou Rennes, Department of Hepatology

    Rennes, 35033

    Baptiste Giguet, MD, 02 99 28 53 25 ext. +33, Baptiste.GIGUET@chu-rennes.fr

    Recruiting

  • CHRU Strasbourg, Chirurgie Hepato-bilio-pancreatique et transplantation hepatique Department

    Strasbourg, 67000

    Baptiste Michard, MD, 03 88 12 79 19 ext. +33, baptiste.michard@chru-strasbourg.fr

    Recruiting

  • CHU Purpan Toulouse, Department of Hepatology

    Toulouse, 31059

    Marie-Angèle Robic, MD, 05 61 32 34 14 ext. +33, robic.ma@chu-toulouse.fr

    Recruiting

  • CHU Paul Brousse, Department of Hepatology

    Villejuif, 94800

    Audrey Coilly, MD-PHD, 01 45 59 30 28 ext. +33, audrey.coilly@aphp.fr

    Recruiting

Other trials in France

Germany9 sites, 9 recruiting

  • Department for General, Visceral, Pediatric and Transplant Surgery, Universitätsklinikum Aachen

    Aachen

    Thomas Vogel, MD-PHD

    Recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin

    Nathanael Raschzok, MD-PHD

    Recruiting

  • Gastroenterology, Hepatology, Infectious Diseases and Endocrinology (GHIE) Medizinische Hochschule Hannover

    Hanover

    Richard Taubert, MD-PHD

    Recruiting

  • Universitätsklinikum Jena

    Jena

    Falk Rauchfuss, MD-PHD

    Recruiting

  • Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine

    Kiel

    Felix Braun, MD-PHD

    Recruiting

  • Universität Leipzig

    Leipzig

    Thomas Berg, MD-PHD

    Recruiting

  • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Münster

    Münster

    Andreas Pascher, MD-PHD

    Recruiting

  • Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen

    Tübingen

    Silvio Nadalin, MD-PHD

    Recruiting

  • Universitätsklinikum Würzburg

    Würzburg

    Johan Lock, MD-PHD

    Recruiting

Other trials in Germany

Belgium5 sites, 5 recruiting

  • Hôpital Erasme Université Libre de Bruxelles

    Brussels

    Thierry Gustot, MD-PHD

    Recruiting

  • Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent

    Ghent

    Hasan Eker, MD-PHD

    Recruiting

  • Cliniques Universitaires Saint-Luc (UCLouvain)

    Leuven

    Géraldine Dahlqvist, MD-PHD

    Recruiting

  • UZ Leuven

    Leuven

    Jef Verbeek, MD-PHD

    Recruiting

  • CHU Liège

    Liège

    Olivier Detry, MD-PHD

    Recruiting

Other trials in Belgium

Spain3 sites, 3 recruiting

  • Department of General, Visceral and Transplantation Surgery, Hospital Universitario Virgen de La Arrixaca

    Murcia

    Victor Lopez, MD

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville

    Miguel Angel Gomez Bravo, MD

    Recruiting

  • Hospital General Universitari València

    Valencia

    Marina Berenguer, MD-PHD

    Recruiting

Other trials in Spain

Netherlands2 sites, 2 recruiting

  • Center for Liver Tumors Leiden of the Leiden University Medical Center (LUMC)

    Leiden

    Minneke Coenraad, MD-PHD

    Recruiting

  • Gastroenterology and Hepatology, Rotterdam Erasmus Medical Center

    Rotterdam

    Caroline Den Hoed, MD

    Recruiting

Other trials in Netherlands

Austria1 site, 1 recruiting

  • Universitätsklinik für Allgemeinchirurgie, Klinische Abteilung für Transplantation

    Vienna

    Gabriela Berlakovich, MD-PHD

    Recruiting

Other trials in Austria

About this study

Official title: 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.

Read more

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.

Keywords
Liver transplantation, predictive models, data collection cohort, liver transplantation candidates
Medical subject headings
Liver Cirrhosis, Biliary, Cholangitis, Sclerosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06675604
Study groupRoleWhat they receive
Subset 1Decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology
Subset 2Other 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 3Hepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical primary endpoint considered as the event of interest to be predicted will be a composite of number of participants with mortality or drop out for being too sick on transplantation waiting list.

    • 3-month mortality/dropout for being too sick after listing in subsets 1 and 2
    • 12-month mortality/dropout for being too sick (tumor progression) after listing in subset 3

    Measured: 3 months after listing in subsets 1 & 2 ; 12 months after listing in subset3

Secondary outcomes (9)

  1. Number of participants with 6- and 9-month pre LT mortality dropout for being too sick (all subsets)

    Mortality (all subsets)

    Measured: 6 and 9 months after listing

  2. Causes of death/drop-out for being too sick

    Causes of death/drop-out (all subsets)

    Measured: From date of inclusion until date of death from any cause or date of drop-out for being too sick, whichever came first, assessed up to 12 months

  3. Incidence of delisting for patient's decision or clinical improvement

    delisting for patient's decision or clinical improvement

    Measured: From date of inclusion until date of delisting for patient's decision or clinical improvement, assessed up to 12 months

  4. Time from listing to death/dropout

    Duration from listing to death/dropout (days)

    Measured: From date of listing until date of death from any cause or date of drop-out for being too sick, whichever came first, assessed up to 12 months

  5. Time to transplantation

    Duration from listing to transplantation (days)

    Measured: From date of listing until date of transplantation, assessed up to 12 months

  6. Number of participants with 6-month and 12 month post LT survival in subsets 1 to 3

    Survival in Training cohort subsets 1 to 3

    Measured: 6 months and 12 months after liver transplantation

  7. Number of participants with 12-month HCC recurrence in subset 3

    HCC recurrence in Training cohort subset 3

    Measured: 12 months after liver transplantation

  8. Number of participants with 6-month post-LT survival (all subsets)

    Survival in Validation cohort all subsets

    Measured: 6 month after liver transplantation

  9. 6-month transplant benefit (all subsets)

    Relevant comorbidities (diabetes, hypertension, stroke, coronary disease, cancers, alcohol and tobacco consumption) in Validation cohort all subsets

    Measured: 6 months after liver transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study start4 Feb 2025
  3. Primary completionMar 2028 (estimated)
  4. Study completion4 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06675604
Sponsor's protocol ID
APHP240880
Acronym
LEOPARD TVDCS
Status last verified
Jul 2026
First submitted
21 Oct 2024
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared. Datas are own by Assistance Publique-Hôpitaux de Paris (AP-HP), please contact sponsor for further information.

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