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Clinical Evaluation of a Novel DAB Chromogenic Tissue-Based Assay for Detecting Anti-GABABR Antibodies

Study acronym: GREAT
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07858175
Lead Sponsor Third Affiliated Hospital, Sun Yat-Sen University
Collaborators: Guangzhou KingMed Center for Clinical Lab.Co., Ltd
Conditions
(from sponsor)		 Autoimmune Encephalitis, Anti-NMDAR Encephalitis, Anti-GABABR Encephalitis
Related terms Anti-N-Methyl-D-Aspartate Receptor Encephalitis, Autoimmune Diseases of the Nervous System
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov