[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571670":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":10,"centralContacts":32,"locations":43,"responsibleParty":112,"collaborators":114,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":10,"studyType":145,"phases":10,"briefSummary":146,"conditions":147,"keywords":152,"overallStatus":157,"whyStopped":10,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Subset 1",null,"Decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology",[13],"Other: Standardized assessments and biobanking",{"label":15,"type":10,"description":16,"interventionNames":17},"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",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Subset 3","Hepato-cellular carcinoma as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis",[22],"Other: Standardized assessments, guided tumor biopsy and biobanking",[24,28],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Standardized assessments, guided tumor biopsy and biobanking","Standardized assessment of Scores\n\n* Guided tumor biopsy in patients listed for hepatocellular carcinoma with active tumor at listing in centers not perfoming tumor biopsy on a routine basis\n* Additional blood sampling for biobanking and subsequent analysis of innovative biomarkers and OMICs\n* Urine sampling for biobanking and subsequent analysis of innovative biomarkers\n* Ascite sampling for biobanking and subsequent analysis\n* Tumor sampling for biobanking and subsequent analysis\n* Centralized assay for routine biomarkers",[19],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Standardized assessments and biobanking","* Standardized assessment of Scores\n* Additional blood sampling for biobanking and subsequent analysis of innovative biomarkers and OMICs\n* Urine sampling for biobanking and subsequent analysis of innovative biomarkers\n* Ascite sampling for biobanking and subsequent analysis\n* Tumor sampling for biobanking and subsequent analysis\n* Centralized assay for routine biomarkers",[9,15],[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Christophe DUVOUX, MD-PHD","CONTACT","01 49 81 23 25","+33","christophe.duvoux@aphp.fr",{"name":40,"role":35,"phone":41,"phoneExt":37,"email":42},"Nihel BERREBEH, Project Manager","01 40 27 46 20","nihel.berrebeh@aphp.fr",[44,58,73,86,99],{"facility":45,"status":10,"city":46,"state":47,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Department of Gastroenterology and Hepatology Universitair Ziekenhuis Gent","Ghent","Belgium","BE",{"type":50,"coordinates":51},"Point",[52,53],3.71667,51.05,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":10,"phoneExt":10,"email":10},"Xavier Verhelst, MD-PHD",{"facility":59,"status":10,"city":60,"state":61,"zip":62,"country":61,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Hospital Henri Mondor, Department of Hepatology","Créteil","France","94010","FR",{"type":50,"coordinates":65},[66,67],2.46569,48.79266,{"lat":67,"lon":66},[70],{"name":71,"role":35,"phone":72,"phoneExt":37,"email":38},"Christophe Duvoux, MD-PHD","0149812325",{"facility":74,"status":10,"city":75,"state":76,"zip":10,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Universitätsklinikum Schleswig - Holstein | UKSH · Transplantation Medicine","Kiel","Germany","DE",{"type":50,"coordinates":79},[80,81],10.13489,54.32133,{"lat":81,"lon":80},[84],{"name":85,"role":35,"phone":10,"phoneExt":10,"email":10},"Felix Braun, MD-PHD",{"facility":87,"status":10,"city":88,"state":89,"zip":10,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Italian National Transplant Center","Roma","Italy","IT",{"type":50,"coordinates":92},[93,94],11.10642,44.99364,{"lat":94,"lon":93},[97],{"name":98,"role":35,"phone":10,"phoneExt":10,"email":10},"Silvia Trapani, MD",{"facility":100,"status":10,"city":101,"state":102,"zip":10,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Center for Liver Tumors Leiden of the Leiden University Medical Center (LUMC)","Leiden","Netherlands","NL",{"type":50,"coordinates":105},[106,107],4.49306,52.15833,{"lat":107,"lon":106},[110],{"name":111,"role":35,"phone":10,"phoneExt":10,"email":10},"Minneke Coenraad, MD-PHD",{"type":113,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[115,117,119,122,124,126,128],{"name":116,"class":6},"University of Luxembourg",{"name":118,"class":6},"Hospital Universitario La Fe",{"name":120,"class":121},"ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN)","UNKNOWN",{"name":123,"class":121},"Ophiomics - Precision Medicine",{"name":125,"class":121},"EF CLIF",{"name":127,"class":121},"INSERM 1149",{"name":129,"class":130},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV","100571670","leopard-prospective-validation-cohort-1-100571670",false,"NCT06723275","LEOPARD Prospective Validation Cohort 1","Validation of LEOPARD Predictive Models of Delisting in Liver Transplant Candidates: the LEOPARD Longitudinal Multicentre Prospective Validation Cohort 1, with Bio- and Tissue Collection","LEOPARD PVC1","Inclusion Criteria:\n\n* Adult \\[age 18;70\\] patients listed for:\n\n  * decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset1) OR\n  * 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\n  * HCC as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on Barcelona\u002FEASL 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 are affected or not.\n* 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.\n* Patient affiliated with a health insurance scheme (beneficiary or entitled party).\n\nExclusion Criteria:\n\n* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging on pre transplantation work-up, including PVT stage 1\n* Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT\u002FMRI) or histologically proven\n* Women who are pregnant or nursing\n* Patients who are under safeguard of justice or tutorship or curatorship\n* Patient on AME (state medical aid)\n* 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","ALL","18 Years","70 Years",{"count":143,"type":144},630,"ESTIMATED","OBSERVATIONAL","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.\n\nMELD based-liver graft allocation systems have become increasingly inaccurate over the last decade to predict mortality\u002Fdropout of liver transplantation (LT) candidates on the waitlist (WL). Wide disparities in mortality\u002Fdropout 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.\n\nHypothesis\u002FObjective The scientific justification of the LEOPARD PVC1 is therefore\n\n1. 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).\n2. 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.\n\nThe primary objective of the LEOPARD longitudinal study is to test and validate AI-based 2nd generation LEOPARD predictive models of mortality\u002Fdrop out on the waitlist in patients with decompensated cirrhosis, or other end-stage chronic liver diseases, and in patients listed for HCC.\n\nMethod 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.",[148,149,150,151],"Decompensated Liver Cirrhosis","Primary Biliary Cholangitis","Primary Sclerosing Cholangitis","Hepato-cellular Carcinoma",[153,154,155,156],"Liver transplantation","Predictive models","Liver transplantation candidates","prospective longitudinal study","NOT_YET_RECRUITING","2024-12-10",{"date":160,"type":161},"2024-12-13","ACTUAL",{"date":163,"type":144},"2025-01",{"date":165,"type":144},"2027-10",{"name":5,"class":6},5]