[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641243":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":23,"locations":29,"responsibleParty":47,"collaborators":51,"id":57,"slug":10,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":80,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Hospital General Universitario Gregorio Marañon","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"NIT-Negative Cohort",null,"High-risk patients (age 50-75 years with ≥1 metabolic risk criterion) in whom FIB-4 was automatically calculated by the LIS and found to be ≤1.30. These patients do not undergo further NIT evaluation and are followed as the non-exposed reference cohort.",{"label":13,"type":10,"description":14,"interventionNames":10},"NIT-Positive Cohort","High-risk patients with FIB-4 \\>1.30 in whom ELF and MASEF were reflexively determined from the same serum sample. Patients with ELF ≥9.8 or MASEF ≥0.33 are referred to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical assessment.",[16,20],{"name":17,"affiliation":18,"role":19},"Rafael Bañares, Full-Professor of Medicine","Universidad Complutense de Madrid, President of Spanish Association for the Study of the Liver (AEEH)","STUDY_CHAIR",{"name":21,"affiliation":22,"role":19},"Magdalena Salcedo, MD, PhD","President of the Spanish Society of Liver Transplantation (SETH)",[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Luis Ibáñez-Samaniego, MD, PhD","CONTACT","+34 91 586 8308","luis.ibanez@salud.madrid.org",[30],{"facility":31,"status":32,"city":33,"state":33,"zip":34,"country":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Hospital General Universitario Gregorio Marañón","RECRUITING","Madrid","28007","Spain",{"type":37,"coordinates":38},"Point",[39,40],-3.70256,40.4165,{"lat":40,"lon":39},[43,44],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},{"name":45,"role":26,"phone":10,"phoneExt":10,"email":46},"Susana Sanchez Berdial, Pharm","ssberdial@salud.madrid.org",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Luis Ibañez","Luis Ibáñez-Samaniego MD, PhD - Senior Consultant in Hepatology",[52,54],{"name":53,"class":6},"Instituto de Investigación Sanitaria Gregorio Marañón",{"name":55,"class":56},"Consorcio Centro de Investigación Biomédica en Red (CIBER)","OTHER_GOV","100641243",false,"NCT07658755","Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme","Towards Universal Screening for Metabolic Dysfunction-Associated Liver Fibrosis in Primary Care: Evaluation of a Single-Step, Laboratory Informatión System-Driven Automated Case-Finding Strategy (LiverSeek)","LiverSeek","Inclusion Criteria:\n\n1. Age between 50 and 75 years (inclusive)\n2. Routine blood test processed in the Clinical Biochemistry Laboratory of Hospital General Universitario Gregorio Marañón, ordered by a primary care physician in one of the 11 affiliated SERMAS primary care centres\n3. Presence of at least one of the following metabolic risk factor combinations:\n\n   * ALT above the upper limit of normal AND HbA1c ≥6.5%\n   * ALT above the upper limit of normal AND BMI \\>30 kg\u002Fm²\n   * BMI \\>30 kg\u002Fm² AND HbA1c ≥6.5%\n\nExclusion Criteria:\n\n1. Age \\\u003C50 years or \\>75 years\n2. Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation)\n3. Prior fibrosis assessment within the preceding 12 months.","ALL","50 Years","75 Years",{"count":68,"type":69},3000,"ESTIMATED","24 Months","OBSERVATIONAL","LiverSeek is a fully automated, passive case-finding programme for advanced liver fibrosis associated with metabolic dysfunction-associated steatotic liver disease (MASLD) in primary care. The programme operates through the Laboratory Information System (LIS; Modulab\u002FBiwer Analytics) of the Clinical Biochemistry Laboratory at Hospital General Universitario Gregorio Marañón (HGUGM), covering approximately 350,000 inhabitants across 11 peri-urban primary care centres affiliated to SERMAS (Servicio Madrileño de Salud) in Madrid, Spain.\n\nWhen a high-risk patient (age 50-75 years with ≥1 of: ALT above ULN + HbA1c ≥6.5%; ALT above ULN + BMI \\>30; BMI \\>30 + HbA1c ≥6.5%) undergoes a routine blood test in primary care, the LIS automatically calculates FIB-4. If FIB-4 \\>1.30, the system reflexively orders ELF and MASEF from the same serum sample, without any action required from the primary care clinician. Patients with a positive second-step NIT (ELF ≥9.8 or MASEF ≥0.33) receive an automatic alert directing them to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical evaluation.\n\nThe primary objective is to evaluate the prevalence of hepatic fibrosis in the high-risk population using this single-step automated strategy. Secondary objectives include head-to-head diagnostic comparison of FIB-4+ELF vs FIB-4+MASEF vs FIB-4+FAST for histologically-confirmed endpoints (significant fibrosis ≥F2, advanced fibrosis ≥F3, at-risk MASH), evaluation of the Liver Risk Score, and a health-economic analysis. A sub-study evaluates a nurse-led structured lifestyle intervention in NIT-positive patients.",[74,75,76,77,78,79],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Liver Fibrosis","Non-alcoholic Fatty Liver Disease NAFLD","Type 2 Diabetes Mellitus","Obesity","Obesity Type 2 Diabetes Mellitus",[81,82,83,84,85,86,87,88,89,90,91],"MASLD","MAFLD","NAFLD","liver fibrosis","FIB-4","ELF","MASEF","screening","passive screening","advanced practice nurse","lifestyle intervention","2026-06-14",{"date":94,"type":95},"2026-06-22","ACTUAL",{"date":97,"type":95},"2024-10-01",{"date":99,"type":69},"2027-09-01",{"name":5,"class":6},1]