Checks liver transplant waitlist patients to refine predictions of dropout risk
Follows adults with advanced liver disease or liver cancer on the transplant waitlist.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Clichy, Créteil, Montpellier, and Paris, FranceSee the 4 sitesAlso in 4 other countries, 4 sites
- Trial code
- Registry title
- LEOPARD Prospective Validation Cohort 1
- Status
- Recruiting
- People taking part
- 630 people, planned
- Started
- 7 Jul 2026
- Expected to end
- 7 Apr 2029
- Type of study
- Observational, 3 groups
- Treatments tested
- Standardized assessments, guided tumor biopsy and biobanking
- Standardized assessments and biobanking
- Record updated
- 29 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 who are on a waiting list for a liver transplant because of decompensated cirrhosis, another end-stage liver disease, or liver cancer (HCC).
- Age
- 18 to 70 years
- Sex
- Women and men can join.
- Disease stage
- Decompensated cirrhosis of any cause, other end-stage liver disease needing a transplant (such as primary biliary cholangitis or primary sclerosing cholangitis), or HCC (liver cancer) with or without cirrhosis.
Main reasons for not taking part
- Tumour growing into the portal or hepatic veins on imaging, including PVT stage 1
- HCC that has spread outside the liver
- Pregnant or nursing women
- Taking part in another trial, including other LEOPARD project studies
- Under legal protection (safeguard of justice, tutorship or curatorship) or on AME (state medical aid)
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Tumor vascular invasion (portal or hepatic veins) evidenced by imaging on pre transplantation work-up, including PVT stage 1
- 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
- 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)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in France
Also in 4 other countries, 4 sites
- Beaujon Hospital, Department of HepatologyClichy, FranceContact: Olivier Roux, MDTaking people
- Hospital Henri Mondor, Department of HepatologyCréteil, FranceContact: Christophe Duvoux, MD-PHDTaking people
- St Eloi Hospital, Department of Hepato-gastro-enterology,Montpellier, FranceContact: Jose Ursic-Bedoya, MD-PHDTaking people
- Hospital La Pitié Salpêtrière, Department of Hepato-gastro-enterologyParis, FranceContact: Alessandra Mazzola, MDTaking people
About the trial
What the trial wants to find out
Intro:
Read full original descriptionShow less
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. 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 PVC1 is therefore
1. to build an external cohort of LT candidates to test and validate the LEOPARD models, therefore providing robust evidence for adoption of LEOPARD models by Organ Sharing Organizations (OSOs). 2. to collect granular data, bio- and tissues sampes and images to test last-generation OMICs predictors and radiomics, therefore opening the door to design of 3rd generation, precision medicine-based predictive models.
The primary objective of the LEOPARD longitudinal study is to test and validate AI-based 2nd generation LEOPARD 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 HCC.
Method Multicenter Prospective longitudinal study in up to 630 enrolments (in case of replacing participants after inclusion) to obtain 600 patients meeting selection criteria, in 30 hospitals in 5 European countries including France, Italy, The Netherlands, Belgium and Germany.
The 3 groups in the trial
- Subset 1
Decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology
Treatment: Standardized assessments and biobanking
- Subset 2
Other chronic end-stage liver diseases requiring LT, listed under MELD offering schemes, including notably but not exclusively cholestatic diseases, primary biliary cholangitis, primary sclerosing cholangitis
Treatment: Standardized assessments and biobanking
- Subset 3
Hepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis
Treatment: Standardized assessments, guided tumor biopsy and biobanking
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Validation of LEOPARD Predictive Models of Delisting in Liver Transplant Candidates: the LEOPARD Longitudinal Multicentre Prospective Validation Cohort 1, With Bio- and Tissue Collection
- Plain-language title
- Checks liver transplant waitlist patients to refine predictions of dropout riskGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06723275, who can take part
- Record updated
- 29 July 2026