LEOPARD: Predicting liver transplant dropout with AI in European patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

LEOPARD is a European project aimed at creating and validating predictive models of mortality for liver transplant candidates. The PVC1 study collects standardized clinical data, tumor biopsies, and biobanked samples to develop second-generation machine learning tools. It uses observational, longitudinal data from adults listed for liver transplant across multiple European centers. The goal is to improve timely access and equity in liver transplantation by better identifying those at greatest risk of delisting. The study does not test a treatment, but rather develops and validates predictive models using real-world waitlist data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult \[age 18;70\] patients listed for:

  * decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset1) OR
  * other end-stage liver diseases requiring LT, listed under MELD offering schemes (subset 2), including notably but not exclusively cholestatic diseases, primary biliary cholangitis, primary sclerosing cholangitis (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 are affected or not.
* Patient (or trusted person, family member or close relation, if the patient is unable to express consent) who has been informed and signed the informed consent.
* Patient affiliated with a health insurance scheme (beneficiary or entitled party).

Exclusion Criteria:

* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging on pre transplantation work-up, including PVT stage 1
* Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT/MRI) or histologically proven
* Women who are pregnant or nursing
* Patients who are under safeguard of justice or tutorship or curatorship
* Patient on AME (state medical aid)
* Participation in another trial including other studies proposed as part of the European LEOPARD project (cohort associated to WP1 \& WP5 ("LEOPARD TVDCS") or being in the exclusion period following previous interventional research involving the human person, if applicable

Where it's running

• Beaujon Hospital, Department of Hepatology
  Clichy, France, France Recruiting
• Hospital Henri Mondor, Department of Hepatology
  Créteil, France, France Recruiting
• St Eloi Hospital, Department of Hepato-gastro-enterology,
  Montpellier, France, France Recruiting
• Hospital La Pitié Salpêtrière, Department of Hepato-gastro-enterology
  Paris, France, France Recruiting
• Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent
  Ghent, Belgium, Belgium Not yet recruiting
• Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine
  Kiel, Germany, Germany Not yet recruiting

Study contacts

• Study coordinator: Christophe DUVOUX, MD-PHD
• Email: christophe.duvoux@aphp.fr
• Phone: 01 49 81 23 25

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.