[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anti-gababr-encephalitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anti-gababr-encephalitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100658922","clinical-evaluation-of-a-novel-dab-chromogenic-tissue-based-assay-for-detecting-anti-gababr-antibodies-100658922",false,"NCT07858175","Clinical Evaluation of a Novel DAB Chromogenic Tissue-Based Assay for Detecting Anti-GABABR Antibodies","Anti-GABAB Receptor Encephalitis: Evaluation of Autoantibodies by a Novel DAB Chromogenic Tissue-Based Assay - A Multicenter, Blinded, Cross-Sectional Study","GREAT","Inclusion Criteria:\n\nGroup a: age 14-85 years; anti-GABABR antibody CBA positive; diagnosed with GABABR antibody encephalitis. Group b: age 14-85 years; suspected autoimmune encephalitis with acute\u002Fsubacute onset (\\\u003C3 months) and one or more neurological\u002Fpsychiatric symptoms (e.g. memory impairment, seizures, psychiatric\u002Fbehavioral abnormalities); anti-neuronal antibody CBA negative; other etiologies reasonably excluded; identifiable address and resident in the region during treatment; willing to provide informed consent and comply with follow-up. Group c: age 14-85 years; non-autoimmune disease patients (Alzheimer's disease confirmed by serum\u002FCSF AD biomarker testing). Group d: age 14-85 years; anti-NMDAR antibody CBA positive; diagnosed with NMDAR antibody encephalitis.\n\nExclusion Criteria:\n\n1. Residual serum or CSF volume insufficient for DAB-TBA and confirmatory testing.\n2. Sample quality unacceptable (gross hemolysis, lipemia, contamination, or clot).\n3. Freeze-thaw cycles exceeding the predefined limit (specify N).\n4. Key clinical information (final diagnosis, CBA result, or demographic data) unavailable or incomplete.\n5. Sample previously included in this study (repeat sample from the same patient).","ALL","14 Years","85 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","This multicenter, blinded, cross-sectional study aims to evaluate the clinical performance of a novel DAB chromogenic tissue-based assay (TBA) for detecting anti-GABAB receptor (anti-GABABR) antibodies. A total of 300 participants will be enrolled across four groups: (a) 50 patients with anti-GABABR antibody-positive encephalitis; (b) 100 patients with suspected autoimmune encephalitis and negative anti-neuronal antibody cell-based assay (CBA); (c) 50 patients with non-autoimmune disease (Alzheimer's disease); and (d) 100 patients with anti-NMDAR antibody-positive encephalitis. Residual serum and cerebrospinal fluid samples will be tested using the optimized DAB-TBA. Discordant results between CBA and DAB-TBA will be adjudicated by an independent panel using confirmatory methods (immunoblot, repeat CBA, and clinical follow-up), and inter-reader agreement will be reported. The sensitivity, specificity, and ROC curve of the assay will be evaluated against the reference standard.",[26,27,28],"Autoimmune Encephalitis","Anti-NMDAR Encephalitis","Anti-GABABR Encephalitis",[30,31,32,33,34],"GABABR","autoimmune encephalitis","DAB","tissue-based assay","autoantibody","NOT_YET_RECRUITING","2026-10-02",{"date":38,"type":39},"2026-10-05","ACTUAL",{"date":41,"type":22},"2026-10",{"date":43,"type":22},"2028-10",{"name":45,"class":46},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",5]