Collecting data to improve liver transplantation predictions

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

This observational study is part of the LEOPARD European project aimed at developing and validating new predictive models for mortality among liver transplantation candidates. The study addresses the limitations of current MELD-based allocation systems, which have become less accurate in predicting mortality and dropout rates on the waitlist. By utilizing AI and machine learning, the project seeks to identify patients at the highest risk of dropout, thereby improving equity in access to liver transplantation across Europe. Data will be collected from various European centers to support the development of these predictive models.

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 (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

Where it's running

• Universitätsklinik für Allgemeinchirurgie, Klinische Abteilung für Transplantation
  Vienna, Austria Recruiting
• Hôpital Erasme Université Libre de Bruxelles
  Brussels, Belgium Recruiting
• Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent
  Ghent, Belgium Recruiting
• Cliniques Universitaires Saint-Luc (UCLouvain)
  Leuven, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• CHU Liège
  Liège, Belgium Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

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.