LEOPARD Training and Validation Data Collection Study

Last updated: February 24, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disorders

Connective Tissue Diseases

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT06675604
APHP240880
  • Ages 18-70
  • All Genders

Study Summary

Intro:

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 and countries. 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 TVDCS is therefore to collect a large set of data in liver transplantation candidates listed in Europe a) to design and b) to validate LEOPARD 2nd generation AI-based predictive models of mortality/dropout The primary objective is to develop new 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 Hepato-cellular carcinoma (HCC).

Method:

Longitudinal multicenter prospective health care data collection cohort study in 2 sets : Training/development set : Prospective health care data collection in 3,000 patients listed in 50 centres across 7 countries and Validation set: Prospective health care data collection in 1,500 subsequent patients listed in the same 50 centres.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult [age 18;70] patients listed for:

  • decompensated cirrhosis as primary diagnosis, irrespective of liver diseaseetiology (subset 1) OR

  • other chronic end-stage liver diseases requiring LT, to be listed under aMELD-based allocation system (examples: primary biliary cholangitis, primarysclerosing cholangitis etc...) (subset 2) OR

  • HCC* as primary diagnosis, whatever the etiology of the underlying liverdisease with or without underlying cirrhosis (subset 3). (HCC diagnosed onBarcelona/EASL criteria or histologically proven. HCC meeting or not Milancriteria, 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 isunable to be informed) who has been informed and did not express opposition to datacollection

(*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

Exclusion Criteria:

  • Tumor vascular invasion (portal or hepatic veins) evidenced by imaging at pretransplantation work-up, including portal vein thrombosis stage 1

  • Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functionalimaging (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

Study Design

Total Participants: 4500
Study Start date:
February 04, 2025
Estimated Completion Date:
February 04, 2029

Connect with a study center

  • Universitätsklinik für Allgemeinchirurgie, Klinische Abteilung für Transplantation

    Vienna,
    Austria

    Site Not Available

  • Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent

    Ghent,
    Belgium

    Site Not Available

  • Hospital Henri Mondor, Department of Hepatology

    Créteil,
    France

    Active - Recruiting

  • Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine

    Kiel,
    Germany

    Site Not Available

  • Italian National Transplant Center

    Rome,
    Italy

    Site Not Available

  • Center for Liver Tumors Leiden of the Leiden University Medical Center (LUMC)

    Leiden,
    Netherlands

    Site Not Available

  • Servicio de HepatologíaHospital Universitario y Politécnico La Fe

    Valencia,
    Spain

    Site Not Available

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