Autoimmune EncephalitisGREATNCT07858175
Clinical Evaluation of a Novel DAB Chromogenic Tissue-Based Assay for Detecting Anti-GABABR Antibodies
An observational study of Autoimmune Encephalitis and Anti-NMDAR Encephalitis, run by Third Affiliated Hospital, Sun Yat-Sen University at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Autoimmune Encephalitis, Anti-NMDAR Encephalitis, Anti-GABABR Encephalitis
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- Oct 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Residual serum or CSF volume insufficient for DAB-TBA and confirmatory testing.
- 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.
- Sample previously included in this study (repeat sample from the same patient).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 518000
Yuanqi Zhao, MD, +86-19120265011, tcm2008@126.com
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 518000
Mingshu Mo, MD, +86-15975632425, momingshu123@163.com
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 518000
Xiaoyan Liu, MD, +86-13527719577, 591713041@qq.com
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 518000
Wei Qiu, MD, +86-15899968330, qiuwei120@vip.163.com
Shu, MD, +86-13724865420, shuyaqing@126.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yanjie Jia, MD, +86-13513802916, Jiayanjie1971@zzu.edu.cn
About this study
Official title: Anti-GABAB Receptor Encephalitis: Evaluation of Autoantibodies by a Novel DAB Chromogenic Tissue-Based Assay - A Multicenter, Blinded, Cross-Sectional Study
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.
Read the detailed description
Anti-GABAB receptor (anti-GABABR) encephalitis is a recognized subtype of autoimmune encephalitis. Antibody detection is essential for diagnosis and differential diagnosis, and cell-based assays (CBA) are the current recommended reference method. The tissue-based assay (TBA) using DAB chromogenic immunohistochemistry offers a widely accessible complement for detecting anti-neuronal antibodies. This study validates the clinical performance of a novel DAB chromogenic TBA developed by Guangzhou KingMed Diagnostics Center. Participants are recruited from neurology departments across multiple centers and enrolled into four groups based on clinical diagnosis and CBA results. Residual serum and CSF samples (no additional sampling) are tested in a blinded manner, and the sensitivity, specificity, and ROC curve of the DAB-TBA for detecting anti-GABABR antibodies are evaluated against the reference standard.
- Keywords
- GABABR, autoimmune encephalitis, DAB, tissue-based assay, autoantibody
- Medical subject headings
- Autoimmune Diseases of the Nervous System, Anti-N-Methyl-D-Aspartate Receptor Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Anti-GABABR antibody-positive encephalitis group (n=50) | |
| Group B | Suspected AE with negative anti-neuronal antibody CBA (n=100) | |
| Group C | Non-autoimmune disease group: Alzheimer's disease (n=50) | |
| Group D | Anti-NMDAR antibody-positive encephalitis group (n=100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 3 months
Secondary outcomes (3)
Cohen's kappa coefficient between DAB-TBA and CBA reference method
Concordance between the novel DAB chromogenic TBA and the CBA reference method for anti-GABABR antibody detection, quantified by Cohen's kappa coefficient.
Measured: up to 3 months
Agreement between serum and CSF detection results by DAB-TBA
Concordance of DAB chromogenic TBA results between paired serum and CSF samples, expressed as agreement percentage and Cohen's kappa.
Measured: up to 3 months
Subgroup detection performance of DAB-TBA
Sensitivity and specificity of the DAB chromogenic TBA stratified by the four predefined subgroups (anti-GABABR-positive encephalitis, CBA-negative suspected autoimmune encephalitis, non-autoimmune neurological disease, and anti-NMDAR encephalitis).
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou KingMed Center for Clinical Lab.Co., Ltd
- Responsible party
- Principal investigator, Wei Qiu, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Wei Qiu, MD, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858175
- Sponsor's protocol ID
- GREAT-PRO-v2.2
- Other IDs
- 2025-510-01
- Acronym
- GREAT
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Aggregated study results will be published in peer-reviewed scientific journals.
Publications
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.
PubMed 37503513Spagni 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.
PubMed 36270951Gresa-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.
PubMed 24360484Papi 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.
PubMed 40393020
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-GABAB Receptor Encephalitis: Evaluation of Autoantibodies by a Novel DAB Chromogenic Tissue-Based Assay - A Multicenter, Blinded, Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07858175
- Acronym / sponsor ID
- GREAT / GREAT-PRO-v2.2
- Keywords
- GABABR, autoimmune encephalitis, DAB, tissue-based assay, autoantibody
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou KingMed Center for Clinical Lab.Co., Ltd
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anti-GABAB receptor (anti-GABABR) encephalitis is a recognized subtype of autoimmune encephalitis. Antibody detection is essential for diagnosis and differential diagnosis, and cell-based assays (CBA) are the current recommended reference method. The tissue-based assay (TBA) using DAB chromogenic immunohistochemistry offers a widely accessible complement for detecting anti-neuronal antibodies. This study validates the clinical performance of a novel DAB chromogenic TBA developed by Guangzhou KingMed Diagnostics Center. Participants are recruited from neurology departments across multiple centers and enrolled into four groups based on clinical diagnosis and CBA results. Residual serum and CSF samples (no additional sampling) are tested in a blinded manner, and the sensitivity, specificity, and ROC curve of the DAB-TBA for detecting anti-GABABR antibodies are evaluated against the reference standard.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Anti-GABABR antibody-positive encephalitis group (n=50) |
| Group B | – | –Suspected AE with negative anti-neuronal antibody CBA (n=100) |
| Group C | – | –Non-autoimmune disease group: Alzheimer's disease (n=50) |
| Group D | – | –Anti-NMDAR antibody-positive encephalitis group (n=100) |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Residual serum or CSF volume insufficient for DAB-TBA and confirmatory testing.
- 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.
- Sample previously included in this study (repeat sample from the same patient).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of novel DAB chromogenic TBA for detection of anti-GABABR antibodies
Time frame: up to 3 months
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.
Specificity of the novel DAB chromogenic TBA for detection of anti-GABABR antibodies
Time frame: up to 3 months
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.
Area under the ROC curve (AUC) of DAB chromogenic TBA for anti-GABABR antibody detection
Time frame: up to 3 months
ROC curve and AUC value of the novel DAB chromogenic TBA for anti-GABABR antibody detection with CBA as reference standard.
3 secondary outcomes
Cohen's kappa coefficient between DAB-TBA and CBA reference method
Time frame: up to 3 months
Agreement between serum and CSF detection results by DAB-TBA
Time frame: up to 3 months
Subgroup detection performance of DAB-TBA
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 37503513Smith 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.
- Background: PubMed 36270951Spagni 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.
- Background: PubMed 24360484Gresa-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.
- Background: PubMed 40393020Papi 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Aggregated study results will be published in peer-reviewed scientific journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Qiu, MD principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis and Anti-NMDAR Encephalitis, run by Third Affiliated Hospital, Sun Yat-Sen University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Qiu, MD (+86-15899968330, qiuwei120@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of novel DAB chromogenic TBA for detection of anti-GABABR antibodies (time frame: up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07858175, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.