[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649102":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":36,"responsibleParty":52,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":92,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Kayseri City Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 MASLD-Positive",null,"MASLD-Positive - Children with obesity classified as having MASLD by the composite reference standard (ultrasonographic steatosis grading plus cardiometabolic risk factor criteria). All candidate index tests are performed.",[13],"Diagnostic Test: Non-Invasive Multi-Parameter Diagnostic Panel",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2 MASLD-Negative","MASLD-Negative - Children with obesity not meeting the composite reference standard for MASLD. All candidate index tests are performed.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Non-Invasive Multi-Parameter Diagnostic Panel","All participants undergo the same set of index tests at a single study visit: a fasting venous blood sample for serum cytokeratin-18 M30 and M65, fibroblast growth factor 21, retinol-binding protein 4, insulin-like growth factor binding protein 7, adiponectin, leptin, insulin and routine biochemistry measured by enzyme-linked immunosorbent assay and standard laboratory methods; abdominal ultrasonography with two-dimensional shear wave elastography for liver stiffness; and genotyping of PNPLA3 rs738409, TM6SF2 rs58542926 and HSD17B13 rs72613567 for derivation of a three-variant polygenic risk score. These are observational measurements; no therapeutic intervention is administered.",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Agah B ÖZTÜRK, MD","Kayseri City Hospital, Kayseri, Türkiye","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Agah Bahadır Öztürk, MD","CONTACT","Türkiye","05058116762","dr-agahoz@hotmail.com",[37],{"facility":5,"status":10,"city":38,"state":10,"zip":39,"country":40,"countryCode":10,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Kayseri","38080","Turkey (Türkiye)",{"type":42,"coordinates":43},"Point",[44,45],35.48528,38.73222,{"lat":45,"lon":44},[48],{"name":49,"role":32,"phone":50,"phoneExt":10,"email":51},"Agah B ÖZTÜRK, Principal Investigator, Department of Pediatrics, MD","+90 352 315 77 00","agahbahadir.ozturk@sbu.edu.tr",{"type":28,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Agah Bahadır Öztürk,MD","Principal Investigator, Department of Pediatrics",[56],{"name":57,"class":58},"Presidency of the Health Institutes of Türkiye","UNKNOWN","100649102","non-invasive-diagnostic-panel-for-masld-in-children-with-obesity-100649102",false,"NCT07731360","Non-Invasive Diagnostic Panel for MASLD in Children With Obesity","A Non-Invasive Diagnostic Panel for MASLD in Children With Obesity: Evaluation of a Multiparametric Biomarker Panel and Genetic Risk Score Using LASSO-Regularized Logistic Regression - The PedMASLD-MultiOmics Pilot Study","PedMASLD-Pilot","Inclusion Criteria:\n\n* Age 8 to 18 years.\n* Body mass index at or above the 85th percentile for age and sex according to Turkish national growth references.\n* Hepatic steatosis of grade 1 or higher on abdominal ultrasonography and\u002For alanine aminotransferase at or above the biology-based upper limit of normal (26 U\u002FL for boys; 22 U\u002FL for girls), or persistent alanine aminotransferase elevation at or above twice the upper limit of normal (50 U\u002FL for boys; 44 U\u002FL for girls).\n* At least one cardiometabolic risk factor.\n* Written informed consent provided by a parent or legal guardian, with simplified assent for children aged 8 to 11 years and standard assent for children aged 12 years and older.\n\nExclusion Criteria:\n\n* Viral hepatitis.\n* Autoimmune liver disease.\n* Wilson disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis.\n* Use of hepatotoxic medication, including corticosteroids, methotrexate, valproate, amiodarone, or tamoxifen.\n* Fasting duration shorter than 12 hours.\n* Active infection, defined as C-reactive protein above 10 mg\u002FL.\n* Untreated thyroid disorder, defined as thyroid-stimulating hormone below 0.5 or above 5.\n* Total parenteral nutrition.\n* Diabetic ketoacidosis.\n* Inability to obtain informed consent.","ALL","8 Years","18 Years",{"count":71,"type":72},180,"ESTIMATED","OBSERVATIONAL","This prospective, single-center, two-group observational study evaluates a non-invasive multi-parameter diagnostic panel for metabolic dysfunction-associated steatotic liver disease (MASLD) in children with obesity. A total of 180 children aged 8 to 18 years with a body mass index at or above the 85th percentile for age and sex are planned for enrollment at a single tertiary pediatric center.\n\nEach participant attends a single study visit comprising a fasting venous blood sample for serum biomarkers (cytokeratin-18 M30 and M65, fibroblast growth factor 21, retinol-binding protein 4, insulin-like growth factor binding protein 7, adiponectin, leptin, insulin, and routine biochemistry), abdominal ultrasonography with two-dimensional shear wave elastography, and genotyping of three MASLD-associated variants (PNPLA3 rs738409, TM6SF2 rs58542926, HSD17B13 rs72613567).\n\nParticipants are classified as MASLD-positive or MASLD-negative according to a guideline-based composite reference standard consisting of ultrasonographic steatosis grading and cardiometabolic risk factor criteria, assessed independently of the candidate index tests. The primary objective is to determine the discriminative performance, expressed as the area under the receiver operating characteristic curve, of a LASSO-regularized logistic regression model combining biomarker, elastography, and genetic predictors. No therapeutic intervention is assigned by the study protocol. Reporting will follow the STARD 2015 statement.",[76,77,78],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Pediatric Obesity","Insulin Resistance Syndrome",[80,81,77,82,83,84,85,86,87,88,89,90,91],"MASLD","NAFLD","Non-Invasive Diagnosis","Cytokeratin-18","FGF21","RBP4","IGFBP7","Shear Wave Elastography","PNPLA3","Polygenic Risk Score","LASSO","Diagnostic Accuracy","NOT_YET_RECRUITING","2026-07-29",{"date":95,"type":96},"2026-07-30","ACTUAL",{"date":98,"type":72},"2026-07-01",{"date":100,"type":72},"2027-06-01",{"name":5,"class":6},1]