[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100390983":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":32,"collaborators":7,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":7,"enrollmentInfo":43,"targetDuration":7,"studyType":46,"phases":7,"briefSummary":47,"conditions":48,"keywords":58,"overallStatus":17,"whyStopped":7,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"LUCA MIELE, MD, PhD","CONTACT","+390631051","luca.miele@policlinicogemelli.it; luca.miele@unicatt.it",[15],{"facility":16,"status":17,"city":18,"state":19,"zip":20,"country":21,"countryCode":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":29},"Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS","RECRUITING","Roma","Rome\u002Flazio\u002Fitaly","00168","Italy","IT",{"type":24,"coordinates":25},"Point",[26,27],11.10642,44.99364,{"lat":27,"lon":26},[30],{"name":31,"role":11,"phone":7,"phoneExt":7,"email":13},"Luca Miele, MD PhD",{"type":33,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100390983","protocol-of-metabolic-and-cryptogenic-liver-disease-registry-for-integration-of-omic-studies-100390983",false,"NCT04371042","PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies","PROMETEO","Inclusion Criteria:\n\n* Age ≥18 years\n* Clinical phenotype of NAFLD (simple steatosis, NASH, metabolic cirrhosis, NAFLD-HCC) based on any of:\n* Liver biopsy providing histological evidence of NAFLD or,\n* Biochemical and\u002For radiological findings consistent with NAFLD\n* Average alcohol consumption ≤21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.\n* Clearance of HCV infection with new DAAs drugs with a SVR (sustained virological response) period \\> 6 months\n* Presence of risk factors for NAFLD (i.e. diabetes, metabolic syndrome, obesity, psoriasis) and absence of fatty liver at US\n\nExclusion Criteria:\n\n* Refusal or inability (lack of capacity) to give informed consent.\n* Average alcohol ingestion \\>21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.\n* History or presence of Type 1 diabetes mellitus.\n* Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.","ALL","18 Years",{"count":44,"type":45},5000,"ESTIMATED","OBSERVATIONAL","The main aim of the study is to set up an observational cohort with NAFLD (Non-alcoholic fatty liver disease) at different stage of disease (from simple steatosis to cirrhosis and\u002For HCC-Hepatocellular carcinoma) and for comparative purpose a cohort of subjects with diabetes and\u002For obesity and\u002For other risk factors (i.e. psoriasis, IBD (inflammatory bowel disease), dyslipidemia) without NAFLD in order to have a clinical phenotypical characterization and the collection of biological specimens.\n\nWe will collect clinical data, biological samples and imaging results in order to perform future cross-sectional studies and\u002For longitudinal studies for elucidating pathways of the disease and develop and validate biomarkers for diagnosis, prognosis and monitoring liver disease and comorbidities in order to contribute to precision medicine in this field.",[49,50,51,52,53,54,55,56,57],"NAFLD - Nonalcoholic Fatty Liver Disease","Diabetes","Obesity","Metabolic Syndrome","Cirrhosis","Liver Cancer","NASH - Nonalcoholic Steatohepatitis","HCC - Hepatocellular Carcinoma","Fatty Liver",[59,60,61,62,63,64],"NAFLD","NASH","NON-ALCHOLIC","LIVER","CIRRHOSIS","HEPATOCELLULAR CARCINOMA","2020-04-28",{"date":67,"type":68},"2020-05-01","ACTUAL",{"date":70,"type":68},"2019-09-01",{"date":72,"type":45},"2035-12-31",{"name":5,"class":6},1]