[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514859":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":21,"responsibleParty":84,"collaborators":87,"id":99,"slug":7,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":7,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":7,"maxAge":7,"enrollmentInfo":106,"targetDuration":109,"studyType":110,"phases":7,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":24,"whyStopped":7,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"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",[22,37,48,58,68,76],{"facility":23,"status":24,"city":25,"state":26,"zip":7,"country":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Hospital Mutua Terrassa","RECRUITING","Terrassa","Barcelona","Spain",{"type":29,"coordinates":30},"Point",[31,32],2.01667,41.56667,{"lat":32,"lon":31},[35],{"name":36,"role":15,"phone":7,"phoneExt":7,"email":7},"Albert Martin Cardona",{"facility":38,"status":24,"city":39,"state":39,"zip":7,"country":27,"cosmosGeoPoint":40,"geoPoint":44,"contacts":45},"Hospital Universitario Lucus Augusti","Lugo",{"type":29,"coordinates":41},[42,43],-7.55602,43.00992,{"lat":43,"lon":42},[46],{"name":47,"role":15,"phone":7,"phoneExt":7,"email":7},"Julia María Cabo del Riego",{"facility":11,"status":24,"city":49,"state":49,"zip":50,"country":27,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Madrid","28046",{"type":29,"coordinates":52},[53,54],-3.70256,40.4165,{"lat":54,"lon":53},[57],{"name":10,"role":15,"phone":7,"phoneExt":7,"email":17},{"facility":59,"status":24,"city":26,"state":7,"zip":7,"country":27,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Hospital Sant Joan de Deu",{"type":29,"coordinates":61},[62,63],2.15899,41.38879,{"lat":63,"lon":62},[66],{"name":67,"role":15,"phone":7,"phoneExt":7,"email":7},"Elisabet Poyatos",{"facility":69,"status":24,"city":49,"state":7,"zip":7,"country":27,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Hospital Ramon y Cajal",{"type":29,"coordinates":71},[53,54],{"lat":54,"lon":53},[74],{"name":75,"role":15,"phone":7,"phoneExt":7,"email":7},"Garbiñe Roy Ariño",{"facility":77,"status":24,"city":49,"state":7,"zip":7,"country":27,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Hospital Universitario Fundación Jimenez Diaz",{"type":29,"coordinates":79},[53,54],{"lat":54,"lon":53},[82],{"name":83,"role":15,"phone":7,"phoneExt":7,"email":7},"María José Martínez Becerra",{"type":12,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Marta Molero","Doctor",[88,90,91,93,94,96],{"name":89,"class":6},"Hospital Mutua de Terrassa",{"name":59,"class":6},{"name":92,"class":6},"Hospital Universitario Ramon y Cajal",{"name":38,"class":6},{"name":95,"class":6},"Hospital Universitario Fundación Jiménez Díaz",{"name":97,"class":98},"Instituto de Investigación Sanitaria Hospital Clínico San Carlos","UNKNOWN","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":107,"type":108},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).",[113],"Celiac Disease",[115,116],"anti-transglutaminase IgA","no-biopsy approach","2025-08-01",{"date":119,"type":120},"2025-08-06","ACTUAL",{"date":122,"type":120},"2023-01-02",{"date":124,"type":108},"2026-03-31",{"name":5,"class":6},6]