Autoimmune Diseases Clinical Trial
— STANDOfficial title:
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
Verified date | June 2022 |
Source | Beijing Tiantan Hospital |
Contact | Fu-Dong Shi |
Phone | +861059976585 |
fshi[@]tmu.edu.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 2500 |
Est. completion date | June 30, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. The patients with suspected NMOSD, MOGAD and AE will be recruited. 2. Male and female patients, = 18 years old. Exclusion Criteria: 1. Abnormal sera, such as hemolysis or lipemia, which will affect the final interpretation of CBA and CBA-TSA; 2. The samples with incomplete clinical data that would affect the disease characterization. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital | Tianjin Medical University General Hospital |
China,
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. — View Citation
Zhang 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Compared with CBA, CBA-TSA uses a smaller sample and costs less, but the experiment turn-around time takes longer. | Comparsion the detection time, costs and sample usage of CBA and CBA-TSA assay in autoantibodies detection of AQP4, MOG, NMDAR. | 2022.6.30-2024.6.30 |
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