[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519581":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":35,"locations":42,"responsibleParty":57,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":77,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Children's Hospital, Zurich","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LD_Diff_Diag",null,"LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician",[13],"Procedure: venous blood puncture",{"label":15,"type":10,"description":16,"interventionNames":17},"Heathy_Control","Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","venous blood puncture","Venous blood puncture performed at first hospital contact, and at 28 days, 3 month, and 6 months after hospital admission.\n\nLumbar puncture and joint puncture for the study will be performed if it is indicated due to diagnostic or therapeutic reasons.",[15,9],[25,26],"lumbar puncture","joint puncture",[28,32],{"name":29,"affiliation":30,"role":31},"Patrick M Meyer Sauteur, MD PhD","Division of infectious diseases Univesity Children's Hospital Zurich","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":30,"role":34},"Christoph Berger, MD","STUDY_DIRECTOR",[36,40],{"name":29,"role":37,"phone":38,"phoneExt":10,"email":39},"CONTACT","0041 44 266 78 96","patrick.meyersauteur@kispi.uzh.ch",{"name":33,"role":37,"phone":10,"phoneExt":10,"email":41},"christoph.berger@kispi.uzh.ch",[43],{"facility":44,"status":45,"city":46,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Chidren's Hospital Zurich","RECRUITING","Zurich","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],8.55,47.36667,{"lat":53,"lon":52},[56],{"name":29,"role":37,"phone":38,"phoneExt":10,"email":39},{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[60],{"name":61,"class":6},"University of Zurich","100519581","borrelia-b-cell-diagnostics-100519581",false,"NCT06045416","Borrelia B-cell Diagnostics","Extensive Investigation of Immune Responses Against Borrelia Burgdorferi to Improve Diagnosis of Lyme Disease in Children: an Observational Study (BRILLIANT Study)","BRILLIANT","Inclusion Criteria:\n\n* Patients presenting at the ED with differential diagnosis of LD according to the treating physician\n\nExclusion Criteria:\n\n* Patients will be excluded in cases of primary or secondary immunodeficiency",true,"ALL","1 Month","17 Years",{"count":75,"type":76},502,"ESTIMATED","6 Months","OBSERVATIONAL","The investigators propose a single center, prospective observational study in children with Lyme disease (LD), the Borrelia B-cell diagnostics (BRILLIANT) study, to assess the immune response against Borrelia burgdorferi (Bb) with the following main objectives:\n\n1. Development of Bb-specific ASC ELISpot as a new test method for diagnosis of early LD.\n\n   There is an urgent unmet clinical need for a better diagnostic tool for early LD, as the current standard two-tier testing has low sensitivity in recently infected patients and may show false positive results in recovered patients due to long-term persistence of antibodies against Bb. The measurement of Bb-specific ASC with the ELISpot assay my has the potential to overcome these issues and to improve diagnosis in early LD.\n2. Extensive analysis of the immune response in LD. The immune response in LD is not well understood. Large-scale studies assessing the detailed immune cell subsets\u002Fphenotypes present in blood, CSF, or synovial fluid of LD patients with respective manifestations are lacking.\n3. Isolation and characterization of causative Bb species. Existing literature suggests that Bb genospecies and\u002For genotypes may determine virulence and manifestations, but large-scale studies assessing Bb genospecies\u002Fgenotypes in different manifestation of LD are lacking.\n4. Collection of clinical data about symptoms, severity, routine laboratory and diagnostic test results, treatment, and outcome of LD.\n5. Biobanking samples for analysis in the future.\n\nProject population\n\nInclusion criteria: Children, 0-17 years of age, at University Children's Hospital Zurich:\n\n* LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician.\n* Control cohort: Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department\n\nExclusion criteria: Primary or secondary immunodeficiency.",[81,82],"Lyme Disease","Borrelia Infections",[84,85,86,87],"Borrelia burgdorferi","Lyme disease","Borrelia specific ASCs","Borrelia strains","2026-04-27",{"date":90,"type":91},"2026-04-28","ACTUAL",{"date":93,"type":91},"2024-04-02",{"date":95,"type":76},"2028-11-01",{"name":5,"class":6},1]