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NCT Number: NCT06675604

LEOPARD Training and Validation Data Collection Study

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.

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Key information

Conditions

Decompensated Liver Cirrhosis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Hepato-cellular Carcinoma Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Biliary Cholangitis Primary Sclerosing Cholangitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik für Allgemeinchirurgie, Klinische Abteilung für Transplantation, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  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.

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

    • 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

Secondary outcomes

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

    Time frame: 6 and 9 months after listing

    Mortality (all subsets)

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

    Time frame: 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

    Causes of death/drop-out (all subsets)

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

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

    delisting for patient's decision or clinical improvement

  4. Time from listing to death/dropout

    Time frame: 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

    Duration from listing to death/dropout (days)

  5. Time to transplantation

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

    Duration from listing to transplantation (days)

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

    Time frame: 6 months and 12 months after liver transplantation

    Survival in Training cohort subsets 1 to 3

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

    Time frame: 12 months after liver transplantation

    HCC recurrence in Training cohort subset 3

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

    Time frame: 6 month after liver transplantation

    Survival in Validation cohort all subsets

  9. 6-month transplant benefit (all subsets)

    Time frame: 6 months after liver transplantation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe DUVOUX, MD-PHD

CONTACT

[email protected]

01 49 81 23 25 ext. +33

Nihel BERREBEH, Project Manager

CONTACT

[email protected]

01 40 27 46 20 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • European Society for Organ Transplantation (ESOT)-European Liver and Intestine Transplant Association (ELITA)ELITA
  • Hospital Universitario La Fe
  • Italian National Transplant Centre (CNT)
  • University of Luxembourg

Registry information

Official study title

Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates

Acronym: LEOPARD TVDCS

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Nov 5, 2024
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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