[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514859":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":21,"responsibleParty":85,"collaborators":88,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":7,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":7,"maxAge":7,"enrollmentInfo":108,"targetDuration":111,"studyType":112,"phases":7,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":24,"whyStopped":7,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Instituto de Investigación Hospital Universitario La Paz","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Marta Molero-Luis, Dr","Hospital Universitario La Paz","PRINCIPAL_INVESTIGATOR",[14,18],{"name":10,"role":15,"phone":16,"phoneExt":7,"email":17},"CONTACT","0034660065755","marta.molero@salud.madrid.org",{"name":19,"role":15,"phone":7,"phoneExt":7,"email":20},"Concepción Núñez Pardo de Vera, Dr","conchita.npardo@gmail.com",[22,38,49,59,69,77],{"facility":23,"status":24,"city":25,"state":26,"zip":7,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Hospital Mutua Terrassa","RECRUITING","Terrassa","Barcelona","Spain","ES",{"type":30,"coordinates":31},"Point",[32,33],2.01667,41.56667,{"lat":33,"lon":32},[36],{"name":37,"role":15,"phone":7,"phoneExt":7,"email":7},"Albert Martin Cardona",{"facility":39,"status":24,"city":40,"state":40,"zip":7,"country":27,"countryCode":28,"cosmosGeoPoint":41,"geoPoint":45,"contacts":46},"Hospital Universitario Lucus Augusti","Lugo",{"type":30,"coordinates":42},[43,44],-7.55602,43.00992,{"lat":44,"lon":43},[47],{"name":48,"role":15,"phone":7,"phoneExt":7,"email":7},"Julia María Cabo del Riego",{"facility":11,"status":24,"city":50,"state":50,"zip":51,"country":27,"countryCode":28,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Madrid","28046",{"type":30,"coordinates":53},[54,55],-3.70256,40.4165,{"lat":55,"lon":54},[58],{"name":10,"role":15,"phone":7,"phoneExt":7,"email":17},{"facility":60,"status":24,"city":26,"state":7,"zip":7,"country":27,"countryCode":28,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Hospital Sant Joan de Deu",{"type":30,"coordinates":62},[63,64],2.15899,41.38879,{"lat":64,"lon":63},[67],{"name":68,"role":15,"phone":7,"phoneExt":7,"email":7},"Elisabet Poyatos",{"facility":70,"status":24,"city":50,"state":7,"zip":7,"country":27,"countryCode":28,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Hospital Ramon y Cajal",{"type":30,"coordinates":72},[54,55],{"lat":55,"lon":54},[75],{"name":76,"role":15,"phone":7,"phoneExt":7,"email":7},"Garbiñe Roy Ariño",{"facility":78,"status":24,"city":50,"state":7,"zip":7,"country":27,"countryCode":28,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"Hospital Universitario Fundación Jimenez Diaz",{"type":30,"coordinates":80},[54,55],{"lat":55,"lon":54},[83],{"name":84,"role":15,"phone":7,"phoneExt":7,"email":7},"María José Martínez Becerra",{"type":12,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Marta Molero","Doctor",[89,91,92,94,95,97],{"name":90,"class":6},"Hospital Mutua de Terrassa",{"name":60,"class":6},{"name":93,"class":6},"Hospital Universitario Ramon y Cajal",{"name":39,"class":6},{"name":96,"class":6},"Hospital Universitario Fundación Jiménez Díaz",{"name":98,"class":99},"Instituto de Investigación Sanitaria Hospital Clínico San Carlos","UNKNOWN","100514859","no-biopsy-approach-in-celiac-disease-cut-off-points-for-iga-anti-tissue-transglutaminase-assays-100514859",false,"NCT05983978","No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays","No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays","Inclusion criteria:\n\n* Patients, on gluten-containing diet, with TGt-IgA antibodies \\> Upper Limit of Normal (ULN) and intestinal biopsy confirming celiac disease (CD).\n* Patients with TCRγδ+ \\>10% combined with decrease NK-like intraepithelial lymphocytes in the intestinal epithelium.\n* Paediatric patients who meet ESPGHAN criteria (TGt-IgA antibodies \\>10xULN) without duodenal biopsy performed.\n\nExclusion criteria:\n\n* Patients already diagnosed with CD.\n* Patients who refused duodenal biopsy.\n* Patients with primary or secondary immunodeficiencies.\n* Patients with malignancy.\n* Recruited patients whose remaining serum cannot be sent to the reference centre, whose biopsies are of poor quality or who nod not sign the informed consent from.","ALL",{"count":109,"type":110},150,"ESTIMATED","6 Months","OBSERVATIONAL","The main objective of this multicenter and observational study is to define the optimal threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy.\n\nThe main questions to be answered are:\n\n* Is the anti-tTG-IgA titer cut-off above 10 times the upper limit of normal (ULN) useful in all anti-tTG IgA assays?\n* Is the diagnostic performance of the newly defined cut-offs of anti-tTG-IgA the same in all the evaluated assays?\n* Is the dynamic of the anti-tTG-IgA levels after the introduction of the gluten-free diet (GFD) similar across the different assays included in the study?\n\nThis is a prospective multicenter study that will enroll pediatric and adult patients with new-onset CD during the years 2023 and 2024. Serum from these patients will be collected for the determination of anti-tTG-IgA according to the local methodology (participating hospital) and by the anti-tTG IgA assays most commonly used in our country, which will be centralized in the same reference center (Hospital Universitario La Paz).",[115],"Celiac Disease",[117,118],"anti-transglutaminase IgA","no-biopsy approach","2025-08-01",{"date":121,"type":122},"2025-08-06","ACTUAL",{"date":124,"type":122},"2023-01-02",{"date":126,"type":110},"2026-03-31",{"name":5,"class":6},6]