NCT07858175Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- NCT number
- NCT07858175
What you commit to
- Study type: Observational
- Planned participants: 300
- From Oct 2026 to the primary completion date, Oct 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Sample previously included in this study (repeat sample from the same patient).
Lab values
- Residual serum or CSF volume insufficient for DAB-TBA and confirmatory testing.
Other
- Sample quality unacceptable (gross hemolysis, lipemia, contamination, or clot).
- Freeze-thaw cycles exceeding the predefined limit (specify N).
- Key clinical information (final diagnosis, CBA result, or demographic data) unavailable or incomplete.
Who the study is looking for
- Group 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/subacute onset (\<3 months) and one or more neurological/psychiatric symptoms (e.g. memory impairment, seizures, psychiatric/behavioral 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/CSF AD biomarker testing). Group d: age 14-85 years; anti-NMDAR antibody CBA positive; diagnosed with NMDAR antibody encephalitis.
Age in the registry: 14 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.