Decompensated Liver CirrhosisLEOPARD PVC1NCT06723275
LEOPARD Prospective Validation Cohort 1
An observational study of Decompensated Liver Cirrhosis and Primary Biliary Cholangitis, run by Assistance Publique - Hôpitaux de Paris at 8 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Decompensated Liver Cirrhosis, Primary Biliary Cholangitis, Primary Sclerosing Cholangitis
- What is being tested?
- Standardized assessments, guided tumor biopsy and biobanking and Standardized assessments and biobanking
- How many people
- 630 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 7 Jul 2026to 7 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients consecutively listed for LT for end-stage chronic liver diseases and HCC
Who may be able to join
- 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).
Who cannot join
- 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 applicable
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 5 countries
France4 sites, 4 recruiting
- Recruiting
Beaujon Hospital, Department of Hepatology
Clichy, France, 92110
Olivier Roux, MD, olivier.roux@aphp.fr
- Recruiting
Hospital Henri Mondor, Department of Hepatology
Créteil, France, 94010
Christophe Duvoux, MD-PHD, 0149812325 ext. +33, christophe.duvoux@aphp.fr
- Recruiting
St Eloi Hospital, Department of Hepato-gastro-enterology,
Montpellier, France, 34295
Jose Ursic-Bedoya, MD-PHD, jose.ursicbedoya@chu-montpellier.fr
- Recruiting
Hospital La Pitié Salpêtrière, Department of Hepato-gastro-enterology
Paris, France, 75013
Alessandra Mazzola, MD, alessandra.mazzola2@aphp.fr
Belgium1 site, 1 recruiting
- Not yet recruiting
Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent
Ghent, Belgium
Xavier Verhelst, MD-PHD
Germany1 site, 1 recruiting
- Not yet recruiting
Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine
Kiel, Germany
Felix Braun, MD-PHD
Italy1 site, 1 recruiting
- Not yet recruiting
Italian National Transplant Center
Roma, Italy
Silvia Trapani, MD
Netherlands1 site, 1 recruiting
- Not yet recruiting
Center for Liver Tumors Leiden of the Leiden University Medical Center (LUMC)
Leiden, Netherlands
Minneke Coenraad, MD-PHD
About this study
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
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.
Read more
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
- 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).
- 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.
- Conditions
- Decompensated Liver Cirrhosis, Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Hepato-cellular Carcinoma
- Being tested
- Standardized assessments, guided tumor biopsy and biobanking, Standardized assessments and biobanking
- Keywords
- Liver transplantation, Predictive models, Liver transplantation candidates, prospective longitudinal study
- Medical subject headings
- Liver Cirrhosis, Biliary, Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized assessments, guided tumor biopsy and biobankingOther
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 biobankingOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Subset 1 | Decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology Receives: Other: Standardized assessments and biobanking | |
| 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 Receives: Other: Standardized assessments and biobanking | |
| Subset 3 | Hepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis Receives: Other: Standardized assessments, guided tumor biopsy and biobanking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-month mortality/dropout for being too sick after listing in subsets 1 and 2
- 12-month mortality/dropout for being too sick (tumor progression) after listing in subset 3
Measured: 3 months after listing in subsets 1 & 2 ; 12 months after listing in subset 3
Secondary outcomes (11)
Number of participants with 6-month mortality/dropout for being too sick (subsets 1 to 3)
Mortality/Drop out for being too sick (subsets 1 to 3)
Measured: 6 months after listing
Number of participants with 9-month mortality/dropout for too sick in subsets 1, 2
Mortality/dropout for being too sick
Measured: 9 months after listing
Number of participants with 12-month mortality/dropout for too sick in subset 3
Mortality/dropout for being too sick
Measured: 12 months after listing
Causes of death/drop-out for being too sick
Causes of death/drop-out
Measured: From date of inclusion until date of death from any cause or date of drop-out for being too sick, whichever came first, assessed up to 12 months
Incidence of delisting for patient's decision or clinical improvement
Delisting for patient's decision or clinical improvement
Measured: From date of inclusion until date of delisting for patient's decision or clinical improvement, assessed up to12 months
Time from listing to death/drop-out
Duration from listing to death/dropout (days)
Measured: From date of listing until date of death from any cause or date of drop-out for being too sick, whichever came first, assessed up to 12 months
Time to transplantation
Duration from listing to transplantation (days)
Measured: From date of listing until date of transplantation, assessed up to 12 months
Number of participants with 1-year post transplant survival in subsets 1-2
Survival in subsets 1-2
Measured: 12 months after liver transplantation
Number of participants with 9-month HCC recurrence in subset 3
HCC recurrence in subset 3
Measured: 9 months after liver transplantation
Number of participants with 9-month post transplant survival in subset 3
Post transplant survival in subset 3
Measured: 9 months after liver transplantation
9-month and 12-month transplant benefit in subsets 3 and 1-2, respectively
Relevant comorbidities
Measured: 9 months and 12 months after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start7 Jul 2026
- Primary completion7 Jul 2028 (estimated)
- Study completion7 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723275
- Sponsor's protocol ID
- APHP231778
- Other IDs
- 2024-A00808-39
- Acronym
- LEOPARD PVC1
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- LEOPARD PVC1 / APHP231778
- Conditions
- Decompensated Liver Cirrhosis, Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Hepato-cellular Carcinoma
- Keywords
- Liver transplantation, Predictive models, Liver transplantation candidates, prospective longitudinal study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- 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
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 7 Jul 2028 (estimated)
- Study completion
- 7 Apr 2029 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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
- 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).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subset 1 | – | Other: Standardized assessments and biobankingDecompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology |
| Subset 2 | – | Other: Standardized assessments and biobankingOther 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 |
| Subset 3 | – | Other: Standardized assessments, guided tumor biopsy and biobankingHepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients consecutively listed for LT for end-stage chronic liver diseases and HCC
Key inclusion criteria (7 listed)
- Adult [age 18;70] patients listed for:
- 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).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized assessments, guided tumor biopsy and biobankingStandardized 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 | Other | Subset 3 |
| 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 | Other | Subset 1, Subset 2 |
Primary outcome
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
Time frame: 3 months after listing in subsets 1 & 2 ; 12 months after listing in subset 3
* 3-month mortality/dropout for being too sick after listing in subsets 1 and 2 * 12-month mortality/dropout for being too sick (tumor progression) after listing in subset 3
11 secondary outcomes
Number of participants with 6-month mortality/dropout for being too sick (subsets 1 to 3)
Time frame: 6 months after listing
Number of participants with 9-month mortality/dropout for too sick in subsets 1, 2
Time frame: 9 months after listing
Number of participants with 12-month mortality/dropout for too sick in subset 3
Time frame: 12 months after listing
Causes of death/drop-out for being too sick
Time frame: From date of inclusion until date of death from any cause or date of drop-out for being too sick, whichever came first, assessed up to 12 months
Incidence of delisting for patient's decision or clinical improvement
Time frame: From date of inclusion until date of delisting for patient's decision or clinical improvement, assessed up to12 months
Time from listing to death/drop-out
Time frame: From date of listing until date of death from any cause or date of drop-out for being too sick, whichever came first, assessed up to 12 months
Time to transplantation
Time frame: From date of listing until date of transplantation, assessed up to 12 months
Number of participants with 1-year post transplant survival in subsets 1-2
Time frame: 12 months after liver transplantation
Number of participants with 9-month HCC recurrence in subset 3
Time frame: 9 months after liver transplantation
Number of participants with 9-month post transplant survival in subset 3
Time frame: 9 months after liver transplantation
9-month and 12-month transplant benefit in subsets 3 and 1-2, respectively
Time frame: 9 months and 12 months after liver transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompensated Liver Cirrhosis and Primary Biliary Cholangitis, run by Assistance Publique - Hôpitaux de Paris at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Belgium, Germany, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe DUVOUX, MD-PHD (01 49 81 23 25 ext. +33, christophe.duvoux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 months after listing in subsets 1 & 2 ; 12 months after listing in subset 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.