Actively Recruiting

Age: 18Years - 70Years
All Genders
ID06675604

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Long-term Monitoring

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

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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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