Actively Recruiting
Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-09
4500
Participants Needed
22
Research Sites
48 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
E
European Society for Organ Transplantation (ESOT)-European Liver and Intestine Transplant Association (ELITA)ELITA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are working on the LEOPARD project funded by the European Commission to improve how liver transplant candidates are prioritized. The study focuses on creating and validating new AI-based predictive models to better estimate mortality and dropout risks for patients with decompensated cirrhosis, end-stage chronic liver diseases, or Hepato-cellular carcinoma (HCC) who are on liver transplant waiting lists across Europe. Current MELD-based systems have become less accurate, and mortality rates vary widely by country and condition. This observational study will gather health data prospectively from 4,500 liver transplant candidates across 50 centers in seven countries. The data is collected in two phases: a training set of 3,000 patients and a validation set of 1,500 patients. Participants include those with decompensated cirrhosis, other end-stage liver diseases listed under MELD allocation, and HCC patients with or without cirrhosis. The study does not involve experimental treatments but collects detailed clinical information to develop predictive models. Participants will be monitored for outcomes including death or removal from the transplant list due to health decline, up to 12 months after listing. Researchers will track causes of death or dropout, time to transplantation, and post-transplant survival at 6 and 12 months. Data collection includes longitudinal health records and imaging results, with participants followed according to standard care. The goal is to improve fairness and timing in liver transplant allocation based on more accurate risk predictions.
CONDITIONS
Brief Title
LEOPARD Training and Validation Data Collection Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Listed for liver transplant due to decompensated cirrhosis regardless of liver disease cause
- Listed for liver transplant due to other chronic end-stage liver diseases under MELD allocation
- Listed for liver transplant due to Hepato-cellular carcinoma with or without cirrhosis
- Registered on national transplant waiting lists under MELD offering schemes
- Patient or representative informed and not opposed to data collection
You will not qualify if you...
- Evidence of tumor vascular invasion (portal or hepatic veins) at pre-transplant evaluation
- Extra-hepatic metastasis of Hepato-cellular carcinoma
- Under legal safeguard such as justice, tutorship, or curatorship
- Receiving state medical aid (AME)
- Participating in LEOPARD PVC 1 study of WP2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months after listing
Participants who are listed for liver transplant are observed to collect data on clinical outcomes including mortality, dropout due to illness severity, transplantation, and survival.
Regular clinical assessments according to transplant center schedules
Duration - Up to 12 months after transplantation
Participants who undergo liver transplantation are followed to assess survival and recurrence outcomes.
Follow-up visits up to 12 months post-transplant as per routine care
Trial Site Locations
Total: 22 locations
1
Universitätsklinik für Allgemeinchirurgie, Klinische Abteilung für Transplantation
Vienna, Austria
Actively Recruiting
2
Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent
Ghent, Belgium
Not Yet Recruiting
3
CHU Jean Minjoz Besançon, Department of Hepatology
Besançon, France, 25000
Actively Recruiting
4
CHU Trousseau Tours, Department of Hepatology
Chambray-lès-Tours, France, 37170
Actively Recruiting
5
CHU Beaujon, Department of Hepatology
Clichy, France, 92110
Actively Recruiting
6
Hospital Henri Mondor, Department of Hepatology
Créteil, France, 94010
Actively Recruiting
7
CHU Dijon, Department of Hepatology
Dijon, France, 21069
Actively Recruiting
8
CHRU Huriez Lille, Department of Hepatology
Lille, France, 59000
Actively Recruiting
9
CHU Lyon Croix Rousse, Department of Hepatology
Lyon, France, 69004
Not Yet Recruiting
10
CHU La Timone AP-HM, Department of Hepatology
Marseille, France, 13005
Not Yet Recruiting
11
CHRU Montpellier Saint Eloi, Department of Hepatology
Montpellier, France, 34295
Actively Recruiting
12
CHU L'Archet Nice, Department of Hepatology
Nice, France, 06000
Actively Recruiting
13
CHU La Pitié Salpêtrière, Department of Hepatology
Paris, France, 75013
Actively Recruiting
14
CHU Bordeaux Haut Levêque, Department of Hepatology
Pessac, France, 33604
Actively Recruiting
15
CHU Pontchaillou Rennes, Department of Hepatology
Rennes, France, 35033
Actively Recruiting
16
CHRU Strasbourg, Chirurgie Hepato-bilio-pancreatique et transplantation hepatique Department
Strasbourg, France, 67000
Actively Recruiting
17
CHU Purpan Toulouse, Department of Hepatology
Toulouse, France, 31059
Actively Recruiting
18
CHU Paul Brousse, Department of Hepatology
Villejuif, France, 94800
Actively Recruiting
19
Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine
Kiel, Germany
Actively Recruiting
20
Italian National Transplant Center
Rome, Italy
Not Yet Recruiting
21
Center for Liver Tumors Leiden of the Leiden University Medical Center (LUMC)
Leiden, Netherlands
Not Yet Recruiting
22
Servicio de HepatologíaHospital Universitario y Politécnico La Fe
Valencia, Spain
Not Yet Recruiting
Research Team
C
Christophe DUVOUX, MD-PHD
N
Nihel BERREBEH, Project Manager
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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