Sensitivity and Specificity of TSA-CBA for Autoantibodies Against Neural Antigen Determination
STAND
Comparison of the Specificity, Sensitivity, and Clinical Correlation of Cell-based Assay (CBA) and CBA-TSA (Tyramide Signal Amplification) in Detecting AQP4, MOG, and NMDAR-IgG in Central Nervous System Diseases; a National Multicenter Study
1 other identifier
observational
2,500
1 country
1
Brief Summary
Determination of autoantibodies against fragments derived from neurons, glia, and myelin sheath is instrumental in aiding diagnosis, differential diagnosis, as well as determining disease status of neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), autoimmune encephalitis (AE). Cell based assay (CBA) has been frequently recommended to detect autoantibodies of neuroantigens in the aforementioned neurological disorders. However, antibodies with low abundance or low affinity often fall beyond the threshold of CBA and pose significant challenges in practice. To this end, the investigators adopted a tyramide signal amplification (TSA) technology with the basis of CBA to improve sensitivity. The preliminary results suggest that this TSA-CBA platform is superior to conventional CBA in registered signals of the titer autoantibodies. In elevating the sensitivity, TSA-CBA also preserves antigen confirmation. This prospective study is launched to compare the sensitivity, specificity, clinical correlation between CBA and CBA-TSA, in determining autoantibodies against aquaporin 4 (AQP4-IgG), myelin oligodendrocyte glycoprotein (MOG-IgG), N-methyl-D-aspartate receptor (NMDAR-IgG) in a multicenter, double-blind setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJune 10, 2022
June 1, 2022
1.6 years
May 31, 2022
June 8, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
CBA-TSA is consistent with CBA in terms of specificity and clinical correlation in detecting autoantibodies.
Comparsion the specificity, sensitivity, positive likelihood ratio (LR), negative LR and clinical correlation of CBA and CBA-TSA assay in autoantibodies detection of AQP4, MOG, NMDAR respectively.
2022.6.30-2024.6.30
CBA-TSA is superior to CBA for detecting antibodies to AQP4, MOG, and NMDAR IgG with low abundance and low affinity.
Comparsion the sensitivity of CBA and CBA-TSA assay in detecting the AQP4, MOG or NMDAR IgG in low abundance and low affinity.
2022.6.30-2024.6.30
Secondary Outcomes (1)
Compared with CBA, CBA-TSA uses a smaller sample and costs less, but the experiment turn-around time takes longer.
2022.6.30-2024.6.30
Study Arms (2)
Cell Based Assay (CBA)
The sera samples from patients and control subjects, upon clinic visits, as well as during follow up, will be randomly numbered. All samples will be blindly tested with CBA by different operators.
CBA-TSA Assay
The sera samples from patients and control subjects, upon clinic visits, as well as during follow up, will be randomly numbered. All samples will be blindly tested with CBA-TSA by different operators.
Interventions
Compare the specificity, sensitivity, and clinical correlation between CBA and CBA-TSA, in detecting AQP4, MOG, and NMDAR IgG
Eligibility Criteria
The patients with CNS demyelinating autoimmune diseases (NMOSD, MOGAD, AE)
You may qualify if:
- The patients with suspected NMOSD, MOGAD and AE will be recruited.
- Male and female patients, ≥ 18 years old.
You may not qualify if:
- Abnormal sera, such as hemolysis or lipemia, which will affect the final interpretation of CBA and CBA-TSA;
- The samples with incomplete clinical data that would affect the disease characterization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100010, China
Related Publications (2)
Zhang C, Tian DC, Yang CS, Han B, Wang J, Yang L, Shi FD. Safety and Efficacy of Bortezomib in Patients With Highly Relapsing Neuromyelitis Optica Spectrum Disorder. JAMA Neurol. 2017 Aug 1;74(8):1010-1012. doi: 10.1001/jamaneurol.2017.1336.
PMID: 28692708BACKGROUNDZhang C, Zhang M, Qiu W, Ma H, Zhang X, Zhu Z, Yang CS, Jia D, Zhang TX, Yuan M, Feng Y, Yang L, Lu W, Yu C, Bennett JL, Shi FD; TANGO Study Investigators. Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial. Lancet Neurol. 2020 May;19(5):391-401. doi: 10.1016/S1474-4422(20)30070-3.
PMID: 32333897BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 10, 2022
Study Start
June 30, 2022
Primary Completion
January 30, 2024
Study Completion
June 30, 2024
Last Updated
June 10, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share