Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05414890
Status:
UNKNOWN
Last Update Posted:
2022-06-10
First Post:
2022-05-31
Brief Title:
Sensitivity and Specificity of TSA-CBA for Autoantibodies Against Neural Antigen Determination
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official 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
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAND
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
Detailed Description:
Participants The sera of patients with CNS demyelinating autoimmune diseases NMOSD MOGAD AE
Primary aim 1 Compare the specificity sensitivity and clinical correlation between CBA and CBA-TSA in detecting AQP4 MOG and NMDAR IgG 2 Analyze the advantage of CBA-TSA assay over conventional CBA in detecting antibodies to AQP4 MOG and NMDAR IgG with low abundance and low affinity
Secondary aim Comparison of the turn-around time and the cost of CBA and CBA-TSA in detecting AQP4 MOG and NMDAR IgG
Study design Multicenter double-blind CBA and CBA-TSA methodology comparison
Total cases
1 1000 patients with suspected NMOSD MOGAD and 1000 patients with suspected autoimmune encephalitis AE will be recruited
2 500 normal subjects will be recruited
Trial Period The trial recruiting duration is 1-2 years
Research reagents 1 The reagents for of AQP4 MOG or NMDAR IgG antibody detection via CBA have been developed and validated by the joint effort of Bejing Tiantan Hospital Tianjin General Hospital and Tianjin New Terrain Biological Technology Co Ltd China will be adopted by this study 2 The CBA-TSA antibody IgG assay developed by the three entities and will be adopted for this study
Groups 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 and CBA by different operators
Study Steps
1 Patients recruiting 1000 patients with suspected NMOSD MOGAD and 1000 patients with suspected AE will be recruited according to inclusionexclusion criteria
2 CBACBA-TSA assay Sera samples from patients and control subjects will be randomly numbered and divided into 3 equal parts 500 ulpart All samples will be tested with CBA-TSA and CBA by different blinded operators original value control value turn-around time and cost will all be recorded The difference comparison between CBA and CBA-TSA was completed by Bejing Tiantan Hospital
3 Statistical Methods Each center will provide feedback of the clinical diagnosis and treatment data of the participants to the investigator The investigator will complete the evaluation of respective clinical correlation of the CBA and CBA-TSA methods The statistics and operation of the project are supervised by a third-party audit company
Primary aim 1 Compare the specificity sensitivity and clinical correlation between CBA and CBA-TSA in detecting AQP4 MOG and NMDAR IgG 2 Analyze the advantage of CBA-TSA assay over conventional CBA in detecting antibodies to AQP4 MOG and NMDAR IgG with low abundance and low affinity
Secondary aim Comparison of the turn-around time and the cost of CBA and CBA-TSA in detecting AQP4 MOG and NMDAR IgG
Study design Multicenter double-blind CBA and CBA-TSA methodology comparison
Total cases
1 1000 patients with suspected NMOSD MOGAD and 1000 patients with suspected autoimmune encephalitis AE will be recruited
2 500 normal subjects will be recruited
Trial Period The trial recruiting duration is 1-2 years
Research reagents 1 The reagents for of AQP4 MOG or NMDAR IgG antibody detection via CBA have been developed and validated by the joint effort of Bejing Tiantan Hospital Tianjin General Hospital and Tianjin New Terrain Biological Technology Co Ltd China will be adopted by this study 2 The CBA-TSA antibody IgG assay developed by the three entities and will be adopted for this study
Groups 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 and CBA by different operators
Study Steps
1 Patients recruiting 1000 patients with suspected NMOSD MOGAD and 1000 patients with suspected AE will be recruited according to inclusionexclusion criteria
2 CBACBA-TSA assay Sera samples from patients and control subjects will be randomly numbered and divided into 3 equal parts 500 ulpart All samples will be tested with CBA-TSA and CBA by different blinded operators original value control value turn-around time and cost will all be recorded The difference comparison between CBA and CBA-TSA was completed by Bejing Tiantan Hospital
3 Statistical Methods Each center will provide feedback of the clinical diagnosis and treatment data of the participants to the investigator The investigator will complete the evaluation of respective clinical correlation of the CBA and CBA-TSA methods The statistics and operation of the project are supervised by a third-party audit company
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None