GREAT
Anti-GABAB Receptor Encephalitis: Evaluation of Autoantibodies by a Novel DAB Chromogenic Tissue-Based Assay - A Multicenter, Blinded, Cross-Sectional Study
Sponsor study identifier
Secondary identifiers
OTHER · Ethics Committee of The Third Affiliated Hospital of Sun Yat-sen University
observational
300
1 country
5
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 18, 2026
Actual (reported)October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 5, 2026
Actual (reported)October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Sensitivity of novel DAB chromogenic TBA for detection of anti-GABABR antibodies
Sensitivity of the novel DAB chromogenic tissue-based assay (TBA) for detecting anti-GABABR antibodies, calculated as true positive / (true positive + false negative), using CBA results as the reference standard.
up to 3 months
Specificity of the novel DAB chromogenic TBA for detection of anti-GABABR antibodies
Specificity of the novel DAB chromogenic tissue-based assay (TBA) for detecting anti-GABABR antibodies, calculated as true negative / (true negative + false positive), using CBA results as the reference standard.
up to 3 months
Area under the ROC curve (AUC) of DAB chromogenic TBA for anti-GABABR antibody detection
ROC curve and AUC value of the novel DAB chromogenic TBA for anti-GABABR antibody detection with CBA as reference standard.
Anti-GABABR antibody-positive encephalitis group (n=50)
Suspected AE with negative anti-neuronal antibody CBA (n=100)
Non-autoimmune disease group: Alzheimer's disease (n=50)
Anti-NMDAR antibody-positive encephalitis group (n=100)
Patients aged 14-85 years recruited from neurology departments across participating centers, grouped as: (a) anti-GABABR antibody-positive encephalitis; (b) suspected autoimmune encephalitis with negative anti-neuronal antibody CBA; (c) non-autoimmune disease (Alzheimer's disease); (d) anti-NMDAR antibody-positive encephalitis.
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 518000, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 518000, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 518000, China
Smith TL, Haven TR, Zuromski LM, Luong K, Clardy SL, Peterson LK. High level of agreement in a fixed vs. live cell-based assay for antibodies to myelin oligodendrocyte glycoprotein in a real-world clinical laboratory setting. Front Neurol. 2023 Jul 12;14:1192644. doi: 10.3389/fneur.2023.1192644. eCollection 2023.
Spagni G, Gastaldi M, Businaro P, Chemkhi Z, Carrozza C, Mascagna G, Falso S, Scaranzin S, Franciotta D, Evoli A, Damato V. Comparison of Fixed and Live Cell-Based Assay for the Detection of AChR and MuSK Antibodies in Myasthenia Gravis. Neurol Neuroimmunol Neuroinflamm. 2022 Oct 21;10(1):e200038. doi: 10.1212/NXI.0000000000200038. Print 2023 Jan.
Residual blood serum and CSF
Wei Qiu, MD
Third Affiliated Hospital, Sun Yat-Sen University
First Submitted
September 18, 2026
First Posted
October 5, 2026
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2028
Clinical Characteristics of Patients With Anti-Collapsin Response Mediator Protein 2 Antibodies in Encephalitis or Encephalomyelitis
up to 3 months
Cohen's kappa coefficient between DAB-TBA and CBA reference method
up to 3 months
Agreement between serum and CSF detection results by DAB-TBA
up to 3 months
Subgroup detection performance of DAB-TBA
up to 3 months
Contact the study team to confirm eligibility.
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 518000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Gresa-Arribas N, Titulaer MJ, Torrents A, Aguilar E, McCracken L, Leypoldt F, Gleichman AJ, Balice-Gordon R, Rosenfeld MR, Lynch D, Graus F, Dalmau J. Antibody titres at diagnosis and during follow-up of anti-NMDA receptor encephalitis: a retrospective study. Lancet Neurol. 2014 Feb;13(2):167-77. doi: 10.1016/S1474-4422(13)70282-5. Epub 2013 Dec 18.
Papi C, Milano C, Arlettaz L, Businaro P, Marmolejo L, Naranjo L, Planaguma J, Martinez-Hernandez E, Armangue T, Guasp M, Ruiz-Garcia R, Aguilar E, Gastaldi M, Iorio R, Gaig C, Saiz A, Sabater L, Graus F, Dalmau JO, Spatola M. Assessing Commercial Tissue-Based Assays for Autoimmune Neurologic Disorders (II): Antibodies to Surface Antigens. Neurol Neuroimmunol Neuroinflamm. 2025 Jul;12(4):e200406. doi: 10.1212/NXI.0000000000200406. Epub 2025 May 20.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 5, 2026
Record last verified: 2026-09
Individual participant data will not be shared. Aggregated study results will be published in peer-reviewed scientific journals.
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Source: ClinicalTrials.gov.
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