- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05414890
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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 1000 patients with suspected NMOSD, MOGAD and 1000 patients with suspected autoimmune encephalitis (AE) will be recruited.
- 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:
- Patients recruiting: 1000 patients with suspected NMOSD, MOGAD and 1000 patients with suspected AE will be recruited according to inclusion/exclusion criteria.
- CBA/CBA-TSA assay: Sera samples from patients and control subjects will be randomly numbered and divided into 3 equal parts (500 ul/part). 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.
- 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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fu-Dong Shi
- Phone Number: +861059976585
- Email: fshi@tmu.edu.cn
Study Contact Backup
- Name: Pei Zheng
- Phone Number: 15522085943
- Email: zhengpei307@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100010
- Recruiting
- Beijing Tiantan Hospital
-
Contact:
- Fu-Dong Shi, PhD
- Phone Number: +861059976585
- Email: fshi@tmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patients with suspected NMOSD, MOGAD and AE will be recruited.
- Male and female patients, ≥ 18 years old.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Compare the specificity, sensitivity, and clinical correlation between CBA and CBA-TSA, in detecting AQP4, MOG, and NMDAR IgG
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CBA-TSA is consistent with CBA in terms of specificity and clinical correlation in detecting autoantibodies.
Time Frame: 2022.6.30-2024.6.30
|
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.
Time Frame: 2022.6.30-2024.6.30
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compared with CBA, CBA-TSA uses a smaller sample and costs less, but the experiment turn-around time takes longer.
Time Frame: 2022.6.30-2024.6.30
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Demyelinating Diseases
- Eye Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Myelitis, Transverse
- Optic Neuritis
- Encephalitis
- Nervous System Diseases
- Neuromyelitis Optica
- Autoimmune Diseases
- Autoimmune Diseases of the Nervous System
- Immune System Diseases
Other Study ID Numbers
- IRB2022-YX-066-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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