PSCRecruiting
LEOPARD Prospective Validation Cohort 1
Observational · No treatment assigned · 8 sites · Assistance Publique - Hôpitaux de Paris
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Decompensated Liver Cirrhosis, Primary Biliary Cholangitis and Primary Sclerosing Cholangitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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.
Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 630 participants are expected to take part.
- The study has 3 groups.
- Start date: 2026-07-07.
- Main results expected around 2028-07-07 (estimate from the record).
- 8 study sites listed (4 marked recruiting) in Belgium, France, Germany, Italy and Netherlands.
Groups in this study
- Subset 1
- Subset 2
- Subset 3
Main thing being measured
- Clinical primary endpoint will be a composite of mortality or drop out for being too sick on transplantation waiting list, since kinetics of dropout differs according to LT indications (3 months after listing in subsets 1 & 2 ; 12 months after listing in subset 3)
In the researchers’ words
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…
Words you might see
- MELD score: a score based on lab tests used to estimate how severe liver disease is.
- Cirrhosis: advanced scarring of the liver.
- Decompensated liver disease: advanced liver disease with complications such as fluid build-up or bleeding.
- Cholestasis: reduced or blocked flow of bile.
- Biopsy / histology: a small tissue sample examined under a microscope.
- PBC: primary biliary cholangitis, a different chronic bile-duct disease.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Decompensated Liver Cirrhosis; Primary Biliary Cholangitis; Primary Sclerosing Cholangitis; Hepato-cellular Carcinoma |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Collaborators | University of Luxembourg; Hospital Universitario La Fe; ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN); Ophiomics - Precision Medicine; EF CLIF; INSERM 1149; Institut National de la Santé Et de la Recherche Médicale, France |
| Enrollment | 630 (estimated) |
| Start date | 2026-07-07 |
| Primary completion (est.) | 2028-07-07 |
| First posted | 2024-12-09 |
| Last updated | 2026-07-29 |
| 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 |
| ClinicalTrials.gov ID | NCT06723275 |
Interventions
- Standardized assessments, guided tumor biopsy and biobanking (Other)
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 biob… - Standardized assessments and biobanking (Other)
* 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
Full eligibility criteria (from the record)
Inclusion Criteria:
* 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).
Exclusion Criteria:
* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging on pre transplantation work-up, including PVT stage 1
* 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 applicableLocations (8)
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent | Ghent, Belgium | Belgium | Not yet recruiting |
| Beaujon Hospital, Department of Hepatology | Clichy, France | France | Recruiting |
| Hospital Henri Mondor, Department of Hepatology | Créteil, France | France | Recruiting |
| St Eloi Hospital, Department of Hepato-gastro-enterology, | Montpellier, France | France | Recruiting |
| Hospital La Pitié Salpêtrière, Department of Hepato-gastro-enterology | Paris, France | France | Recruiting |
| Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine | Kiel, Germany | Germany | Not yet recruiting |
| Italian National Transplant Center | Roma, Italy | Italy | Not yet recruiting |
| Center for Liver Tumors Leiden of the Leiden University Medical Center (LUMC) | Leiden, Netherlands | Netherlands | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.