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Collecting data to improve liver transplantation predictions

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

Observational Assistance Publique - Hôpitaux de Paris · NCT06675604

This study is trying to use AI to better predict which liver transplant candidates are at risk of dropping out of the waitlist, so that more people can get fair access to transplants across Europe.

Quick facts

Study typeObservational
Enrollment4500 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAssistance Publique - Hôpitaux de Paris Academic / other
Locations22 sites (Vienna and 21 other locations)
Trial IDNCT06675604 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 who are listed for liver transplantation due to decompensated cirrhosis, other chronic end-stage liver diseases, or hepatocellular carcinoma.

Not a fit: Patients who are not listed for liver transplantation or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate predictions for liver transplantation candidates, ultimately improving patient outcomes and access to transplants.

How similar studies have performed: Other studies have shown success in using predictive modeling for liver transplantation, but this approach aims to enhance existing methods with advanced AI techniques.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Vienna and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Decompensated Liver CirrhosisPrimary Biliary CholangitisPrimary Sclerosing CholangitisHepato-cellular CarcinomaLiver transplantationpredictive modelsdata collection cohortliver transplantation candidates
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.