[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100309481":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":81,"centralContacts":86,"locations":91,"responsibleParty":114,"collaborators":118,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":153,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":57,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":93,"whyStopped":57,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Liver stiffness measurement","EXPERIMENTAL","Transient elastography in fasting state",[13,14,15,16,17,18,19],"Diagnostic Test: transient elastography","Diagnostic Test: Enhanced liver fibrosis test","Diagnostic Test: Indirect serum markers of liver fibrosis","Diagnostic Test: Direct serum markers of liver fibrosis","Diagnostic Test: LiverTRAIL","Diagnostic Test: Cytokeratin 18","Diagnostic Test: Omics markers",[21,29,35,45,53,58,66],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","transient elastography","Ultrasound elastography using shear-wave elastography to measure liver stiffness as a marker of liver fibrosis. Patients with transient elastography above 8.0 kPa selected for liver biopsy to detect advanced liver fibrosis",[9],[27,28],"FibroScan","TE",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Enhanced liver fibrosis test","Patented, commercially available algorithm of hyaluronic acid (HA), N-terminal propeptide of collagen type 3 (P3NP) and tissue inhibitor of metalloproteinase 1 (TIMP-1)",[9],[34],"ELF",{"type":22,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Indirect serum markers of liver fibrosis","Diagnostic markers using combination of routine liver biochemistry: age, AST, ALT, platelet count, cholesterol, GGT",[9],[40,41,42,43,44],"Forns index","FIB-4","APRI","AST-ALT ratio","Age-platelet ratio",{"type":22,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Direct serum markers of liver fibrosis","Serum markers that reflect liver extracellular matrix turnover and -accumulation",[9],[50,51,52],"Neoepitopes","Collagen products","Extracellular matrix",{"type":22,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"LiverTRAIL","Software that contain 199 diagnostic algorithms, containing combinations of routine tests: age, AST, albumin, alkaline phosphatase, bilirubin, GGT, INR, platelet count, cholesterol and sodium, and specialist tests: transient elastography and direct serum markers of fibrosis.",[9],null,{"type":22,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Cytokeratin 18","Cytokeratin 18 from liver cell cytoskeleton; when cells undergo apoptosis, caspase-cleaved CK18 is released (M30), whereas full-length CK18 is realised during necrosis (M65)",[9],[63,64,65],"CK18","M30","M65",{"type":22,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Omics markers","Markers combining signatures of liver fibrosis and hepatic inflammation from many 'omics technologies",[9],[71,72,73,74,75,76,77,78,79,80],"Multi-omics markers","Lipidomics","Microbiomics","Genomics","Metagenomics","Metatranscriptomics","Transcriptomics","miRNA-omics","Metabolomics","Proteomics",[82],{"name":83,"affiliation":84,"role":85},"Maja Thiele, MD, PhD, Professor","Department of Gastroenterology and Hepatology, Odense University Hospital","PRINCIPAL_INVESTIGATOR",[87],{"name":83,"role":88,"phone":89,"phoneExt":57,"email":90},"CONTACT","+4524998068","maja.thiele@rsyd.dk",[92],{"facility":84,"status":93,"city":94,"state":57,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"RECRUITING","Odense","5000","Denmark","DK",{"type":99,"coordinates":100},"Point",[101,102],10.38831,55.39594,{"lat":102,"lon":101},[105,109,111],{"name":106,"role":88,"phone":107,"phoneExt":108,"email":90},"Maja Thiele, MD, PhD","65412752","45",{"name":110,"role":85,"phone":57,"phoneExt":57,"email":57},"Maja Thiele, MD PhD",{"name":112,"role":113,"phone":57,"phoneExt":57,"email":57},"Aleksander Krag, MD PhD Professor","SUB_INVESTIGATOR",{"type":115,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"SPONSOR_INVESTIGATOR","Maja Thiele","Associate professor",[119,121,124,126,129,131,133,135,137,139,141,143,145,147,149],{"name":120,"class":6},"Horizon 2020 - European Commission",{"name":122,"class":123},"Novo Nordisk A\u002FS","INDUSTRY",{"name":125,"class":6},"University of Southern Denmark",{"name":127,"class":128},"Esbjerg University Hospital of South-West Jutland","UNKNOWN",{"name":130,"class":128},"Odense Municipality Alcohol Rehabilitation Unit",{"name":132,"class":128},"Svendborg Municipality Alcohol Rehabilitation Unit",{"name":134,"class":6},"University of Copenhagen",{"name":136,"class":6},"University of Oslo",{"name":138,"class":123},"Nordic Bioscience A\u002FS",{"name":140,"class":128},"VLV Bio, Peviva AB",{"name":142,"class":128},"Manatee APS",{"name":144,"class":123},"Siemens Healthcare A\u002FS",{"name":146,"class":6},"Steno Diabetes Center Copenhagen",{"name":148,"class":6},"Biomedical Research Foundation, Academy of Athens",{"name":150,"class":6},"Heidelberg University","100309481","screening-at-risk-populations-for-hepatic-fibrosis-with-non-invasive-markers-100309481",false,"NCT03308916","Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers","SIPHON","INCLUSION CRITERIA\n\nPatients are eligible for screening if the following inclusion criteria are fulfilled:\n\n* Age 30-75 years (except the general population, which should be aged 40-75)\n* Informed consent to study investigations\n* Ability to read and write Danish AND (only at-risk patients)\n* Prior or current alcohol overuse, defined as an average intake of ≥24 grams\u002Fday (14 units\u002Fweek) for women and ≥36 grams\u002Fday (21 units\u002Fweek) for men, for at least 5 years; OR\n* Presence of the metabolic syndrome defined by central obesity plus any two of the following four metabolic risk factors: (a) raised triglycerides, (b) reduced HDL cholesterol, (c) raised blood pressure and (d) raised fasting plasma glucose;\\[38\\] OR\n* Type 2 diabetes mellitus defined by either fasting plasma glucose ≥7 mmol\u002FL, HbA1c ≥48 mmol\u002Fmol, a random plasma glucose ≥11.1 mmol\u002FL in the presence of classic diabetes or an oral glucose tolerance test with fasting plasma glucose ≥7.0 mmol\u002FL and\u002For 2 hour plasma glucose ≥11.1 mmol\u002FL.\n\nEXCLUSION CRITERIA\n\nWe will exclude patients from screening in case of:\n\n* Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with\u002Fwithout variceal bleeding.\n* Known concurrent liver disease other than ALD and NAFLD.\n* Cancer or other debilitating disease with an expected survival of less than 12 months.\n* Inability to comply with the study protocol.\n\nIn screened patients with liver stiffness ≥8 kPa we will abstain from a liver biopsy in case of:\n\n* Contraindications for a percutaneous liver biopsy\n* Severe alcoholic hepatitis or other hepatic inflammation evidenced by transaminase elevation of more than three times the upper limit of normal.\n* Hepatic congestion or bile duct dilation evidenced by ultrasound.\n* Decrease of TE below 6.0 kPa from screening to time of planned liver biopsy.","ALL","30 Years","75 Years",{"count":162,"type":163},6500,"ESTIMATED","INTERVENTIONAL",[166],"NA","Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.",[169,170],"Liver Diseases, Alcoholic","Fibrosis",[172,173,174,175,176,177,178,179,180,181,182,183,184,185,34,186,187,188,189,190,191,192],"elastography","screening","non-invasive markers","microbiome","gut-liver-axis","cost-benefit","fibroscan","aixplorer","ultrasound elastography","liver fibrosis","alcoholic liver disease","advanced fibrosis","enhanced liver fibrosis test","direct liver fibrosis markers","cytokeratin-18","neoepitopes","collagen","NAFLD","ALD","metabolomics","non-alcoholic fatty liver disease","2022-08-29",{"date":195,"type":196},"2022-09-01","ACTUAL",{"date":198,"type":196},"2017-10-06",{"date":200,"type":163},"2035-10-30",{"name":116,"class":6},1]