Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
630 participants
OBSERVATIONAL
2025-01-31
2027-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subset 1
Decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology
Standardized assessments and biobanking
* Standardized assessment of Scores
* Additional blood sampling for biobanking and subsequent analysis of innovative biomarkers and OMICs
* Urine sampling for biobanking and subsequent analysis of innovative biomarkers
* Ascite sampling for biobanking and subsequent analysis
* Tumor sampling for biobanking and subsequent analysis
* Centralized assay for routine biomarkers
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
Standardized assessments and biobanking
* Standardized assessment of Scores
* Additional blood sampling for biobanking and subsequent analysis of innovative biomarkers and OMICs
* Urine sampling for biobanking and subsequent analysis of innovative biomarkers
* Ascite sampling for biobanking and subsequent analysis
* Tumor sampling for biobanking and subsequent analysis
* Centralized assay for routine biomarkers
Subset 3
Hepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis
Standardized assessments, guided tumor biopsy and biobanking
Standardized assessment of Scores
* Guided tumor biopsy in patients listed for hepatocellular carcinoma with active tumor at listing in centers not perfoming tumor biopsy on a routine basis
* Additional blood sampling for biobanking and subsequent analysis of innovative biomarkers and OMICs
* Urine sampling for biobanking and subsequent analysis of innovative biomarkers
* Ascite sampling for biobanking and subsequent analysis
* Tumor sampling for biobanking and subsequent analysis
* Centralized assay for routine biomarkers
Interventions
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Standardized assessments, guided tumor biopsy and biobanking
Standardized assessment of Scores
* Guided tumor biopsy in patients listed for hepatocellular carcinoma with active tumor at listing in centers not perfoming tumor biopsy on a routine basis
* Additional blood sampling for biobanking and subsequent analysis of innovative biomarkers and OMICs
* Urine sampling for biobanking and subsequent analysis of innovative biomarkers
* Ascite sampling for biobanking and subsequent analysis
* Tumor sampling for biobanking and subsequent analysis
* Centralized assay for routine biomarkers
Standardized assessments and biobanking
* Standardized assessment of Scores
* Additional blood sampling for biobanking and subsequent analysis of innovative biomarkers and OMICs
* Urine sampling for biobanking and subsequent analysis of innovative biomarkers
* Ascite sampling for biobanking and subsequent analysis
* Tumor sampling for biobanking and subsequent analysis
* Centralized assay for routine biomarkers
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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)
* 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
18 Years
70 Years
ALL
No
Sponsors
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University of Luxembourg
OTHER
Hospital Universitario La Fe
OTHER
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN)
UNKNOWN
Ophiomics - Precision Medicine
UNKNOWN
EF CLIF
UNKNOWN
INSERM 1149
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent
Ghent, Belgium, Belgium
Hospital Henri Mondor, Department of Hepatology
Créteil, France, France
Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine
Kiel, Germany, Germany
Italian National Transplant Center
Roma, Italy, Italy
Center for Liver Tumors Leiden of the Leiden University Medical Center (LUMC)
Leiden, Netherlands, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Xavier Verhelst, MD-PHD
Role: primary
Christophe Duvoux, MD-PHD
Role: primary
Felix Braun, MD-PHD
Role: primary
Silvia Trapani, MD
Role: primary
Minneke Coenraad, MD-PHD
Role: primary
Other Identifiers
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2024-A00808-39
Identifier Type: OTHER
Identifier Source: secondary_id
APHP231778
Identifier Type: -
Identifier Source: org_study_id