Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT06675604
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2024-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LEOPARD Training and Validation Data Collection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}, {'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002761', 'term': 'Cholangitis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-02-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical primary endpoint considered as the event of interest to be predicted will be a composite of number of participants with mortality or drop out for being too sick on transplantation waiting list.', 'timeFrame': '3 months after listing in subsets 1 & 2 ; 12 months after listing in subset3', 'description': '* 3-month mortality/dropout for being too sick after listing in subsets 1 and 2\n* 12-month mortality/dropout for being too sick (tumor progression) after listing in subset 3'}], 'secondaryOutcomes': [{'measure': 'Number of participants with 6- and 9-month pre LT mortality dropout for being too sick (all subsets)', 'timeFrame': '6 and 9 months after listing', 'description': 'Mortality (all subsets)'}, {'measure': 'Causes of death/drop-out for being too sick', 'timeFrame': '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', 'description': 'Causes of death/drop-out (all subsets)'}, {'measure': "Incidence of delisting for patient's decision or clinical improvement", 'timeFrame': "From date of inclusion until date of delisting for patient's decision or clinical improvement, assessed up to 12 months", 'description': "delisting for patient's decision or clinical improvement"}, {'measure': 'Time from listing to death/dropout', 'timeFrame': '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', 'description': 'Duration from listing to death/dropout (days)'}, {'measure': 'Time to transplantation', 'timeFrame': 'From date of listing until date of transplantation, assessed up to 12 months', 'description': 'Duration from listing to transplantation (days)'}, {'measure': 'Number of participants with 6-month and 12 month post LT survival in subsets 1 to 3', 'timeFrame': '6 months and 12 months after liver transplantation', 'description': 'Survival in Training cohort subsets 1 to 3'}, {'measure': 'Number of participants with 12-month HCC recurrence in subset 3', 'timeFrame': '12 months after liver transplantation', 'description': 'HCC recurrence in Training cohort subset 3'}, {'measure': 'Number of participants with 6-month post-LT survival (all subsets)', 'timeFrame': '6 month after liver transplantation', 'description': 'Survival in Validation cohort all subsets'}, {'measure': '6-month transplant benefit (all subsets)', 'timeFrame': '6 months after liver transplantation', 'description': 'Relevant comorbidities (diabetes, hypertension, stroke, coronary disease, cancers, alcohol and tobacco consumption) in Validation cohort all subsets'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver transplantation', 'predictive models', 'data collection cohort', 'liver transplantation candidates'], 'conditions': ['Decompensated Liver Cirrhosis', 'Primary Biliary Cholangitis', 'Primary Sclerosing Cholangitis', 'Hepato-cellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Intro:\n\nThe 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.\n\nHypothesis/Objective:\n\nThe 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).\n\nMethod:\n\nLongitudinal 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults patients listed for :\n\n* Decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset 1)\n* Other chronic end-stage liver diseases requiring LT, to be listed under a MELD-based allocation system (examples: primary biliary cholangitis, primary sclerosing cholangitis etc…) (subset 2)\n* Hepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult \\[age 18;70\\] patients listed for:\n\n * decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset 1) OR\n * other chronic end-stage liver diseases requiring LT, to be listed under a MELD-based allocation system (examples: primary biliary cholangitis, primary sclerosing cholangitis etc…) (subset 2) OR\n * 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.)\n* Patients registered on national waiting lists under the MELD offering schemes, regardless of extra MELD points and MELD exceptions are affected or not.\n* Patient (or trusted person, family member or close relation, if the patient is unable to be informed) who has been informed and did not express opposition to data collection\n\n(\\*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.)\n\nExclusion Criteria:\n\n* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging at pre transplantation work-up, including portal vein thrombosis stage 1\n* Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT/MRI) or histologically proven\n* Patients who are under safeguard of justice or tutorship or curatorship\n* Patient on AME (state medical aid)\n* Participation to LEOPARD PVC 1 study of WP2'}, 'identificationModule': {'nctId': 'NCT06675604', 'acronym': 'LEOPARD TVDCS', 'briefTitle': 'LEOPARD Training and Validation Data Collection Study', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates', 'orgStudyIdInfo': {'id': 'APHP240880'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subset 1', 'description': 'Decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology'}, {'label': 'Subset 2', 'description': 'Other chronic end-stage liver diseases requiring LT, to be listed under a MELD-based allocation system (examples: primary biliary cholangitis, primary sclerosing cholangitis etc…)'}, {'label': 'Subset 3', 'description': 'Hepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Gabriela Berlakovich, MD-PHD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinik für Allgemeinchirurgie, Klinische Abteilung für Transplantation', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Ghent', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Xavier Verhelst, MD-PHD', 'role': 'CONTACT'}], 'facility': 'Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Delphine Weil Verhoeven, MD', 'role': 'CONTACT', 'email': 'dweil@chu-besancon.fr', 'phone': '03 81 66 87 54', 'phoneExt': '+33'}], 'facility': 'CHU Jean Minjoz Besançon, Department of Hepatology', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure Elkrief, MD', 'role': 'CONTACT', 'email': 'l.elkrief@chu-tours.fr', 'phone': '02 47 47 59 37', 'phoneExt': '+33'}], 'facility': 'CHU Trousseau Tours, Department of Hepatology', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '92110', 'city': 'Clichy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Roux, MD', 'role': 'CONTACT', 'email': 'olivier.roux@aphp.fr', 'phone': '01 40 87 55 22', 'phoneExt': '+33'}], 'facility': 'CHU Beaujon, Department of Hepatology', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '94010', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe Duvoux, MD-PHD', 'role': 'CONTACT', 'email': 'christophe.duvoux@aphp.fr', 'phone': '01 49 81 23 25', 'phoneExt': '+33'}], 'facility': 'Hospital Henri Mondor, Department of Hepatology', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21069', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marianne Latournerie, MD', 'role': 'CONTACT', 'email': 'marianne.latournerie@chu-dijon.fr', 'phone': '03 80 29 37 50', 'phoneExt': '+33'}], 'facility': 'CHU Dijon, Department of Hepatology', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sébastien Dharancy, MD-PHD', 'role': 'CONTACT', 'email': 'Sebastien.DHARANCY@chru-lille.fr', 'phone': '03 20 44 55 97', 'phoneExt': '+33'}], 'facility': 'CHRU Huriez Lille, Department of Hepatology', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69004', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Teresa Antonini, MD', 'role': 'CONTACT', 'email': 'teresa.antonini@chu-lyon.fr', 'phone': '04 26 73 28 88', 'phoneExt': '+33'}], 'facility': 'CHU Lyon Croix Rousse, Department of Hepatology', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clara Dassetto, MD', 'role': 'CONTACT', 'email': 'Clara.DASSETTO@ap-hm.fr', 'phone': '04 91 38 00 00', 'phoneExt': '+33'}], 'facility': 'CHU La Timone AP-HM, Department of Hepatology', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jose Ursic-Bedoya, MD-PHD', 'role': 'CONTACT', 'email': 'jose.ursicbedoya@chu-montpellier.fr', 'phone': '04 67 33 67 33', 'phoneExt': '+33'}], 'facility': 'CHRU Montpellier Saint Eloi, Department of Hepatology', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rodolphe Anty, MD-PHD', 'role': 'CONTACT', 'email': 'anty.r@chu-nice.fr', 'phone': '04.92.03.66.00', 'phoneExt': '+33'}], 'facility': "CHU L'Archet Nice, Department of Hepatology", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alessandra Mazzola, MD', 'role': 'CONTACT', 'email': 'alessandra.mazzola2@aphp.fr', 'phone': '01 42 17 56 88', 'phoneExt': '+33'}], 'facility': 'CHU La Pitié Salpêtrière, Department of Hepatology', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Faiza Chermak, MD', 'role': 'CONTACT', 'email': 'faiza.chermak@chu-bordeaux.fr', 'phone': '05 57 65 64 39 f', 'phoneExt': '+33'}], 'facility': 'CHU Bordeaux Haut Levêque, Department of Hepatology', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Baptiste Giguet, MD', 'role': 'CONTACT', 'email': 'Baptiste.GIGUET@chu-rennes.fr', 'phone': '02 99 28 53 25', 'phoneExt': '+33'}], 'facility': 'CHU Pontchaillou Rennes, Department of Hepatology', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67000', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Baptiste Michard, MD', 'role': 'CONTACT', 'email': 'baptiste.michard@chru-strasbourg.fr', 'phone': '03 88 12 79 19', 'phoneExt': '+33'}], 'facility': 'CHRU Strasbourg, Chirurgie Hepato-bilio-pancreatique et transplantation hepatique Department', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Angèle Robic, MD', 'role': 'CONTACT', 'email': 'robic.ma@chu-toulouse.fr', 'phone': '05 61 32 34 14', 'phoneExt': '+33'}], 'facility': 'CHU Purpan Toulouse, Department of Hepatology', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94800', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Audrey Coilly, MD-PHD', 'role': 'CONTACT', 'email': 'audrey.coilly@aphp.fr', 'phone': '01 45 59 30 28', 'phoneExt': '+33'}], 'facility': 'CHU Paul Brousse, Department of Hepatology', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Kiel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Felix Braun, MD-PHD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Rome', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Feltrin, MD', 'role': 'CONTACT'}], 'facility': 'Italian National Transplant Center', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Leiden', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Minneke Coenraad, MD-PHD', 'role': 'CONTACT'}], 'facility': 'Center for Liver Tumors Leiden of the Leiden University Medical Center (LUMC)', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Valencia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marina Berenguer, MD-PHD', 'role': 'CONTACT'}], 'facility': 'Servicio de HepatologíaHospital Universitario y Politécnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Christophe DUVOUX, MD-PHD', 'role': 'CONTACT', 'email': 'christophe.duvoux@aphp.fr', 'phone': '01 49 81 23 25', 'phoneExt': '+33'}, {'name': 'Nihel BERREBEH, Project Manager', 'role': 'CONTACT', 'email': 'nihel.berrebeh@aphp.fr', 'phone': '01 40 27 46 20', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared. Datas are own by Assistance Publique-Hôpitaux de Paris (AP-HP), please contact sponsor for further information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Society for Organ Transplantation (ESOT)-European Liver and Intestine Transplant Association (ELITA)ELITA', 'class': 'UNKNOWN'}, {'name': 'University of Luxembourg', 'class': 'OTHER'}, {'name': 'Italian National Transplant Centre (CNT)', 'class': 'UNKNOWN'}, {'name': 'La Fe University hospital Valencia (HULAFE)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}