Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617962
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Evaluation of Two Cell-based Assays for Diagnosing MOG-IgG Associated Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of The Diagnostic Value of Two Cell-based Assays for MOG-IgG-associated Diseases A Multicenter Paired Design Observational Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anti-myelin oligodendrocyte glycoprotein-IgG-associated disorders MOGAD is a rare inflammatory autoimmune disease In addition since the international MOGAD group proposed live-cell based assays for MOGAD diagnosis in 2023 there are still no real-world cohort validation studies on this methodology This study intends to establish a large sample cohort with multi-center and paired design MOG-IgG detection based on live cells and fixed cells was performed on the study participants with high suspicion of MOGAD and the negative control population to obtain the diagnostic performance parameters and consistency evaluation of the two methodologies evaluate their clinical diagnostic value and explore the best individual assay cutoffs for MOG-IgG detection suitable for the diagnosis of MOGAD in China
Detailed Description:
Study design A multicenter observational study to compare the diagnosis performance of two cell-based assays in Chinese patients with idiopathic demyelinating disorders Participants In this study serum samples were collected from participants with high clinical suspicion of MOGAD the number of valid positive cases was 150 and control samples were collected including 30 participants in other inflammatory CNS disease studies 30 participants in non-inflammatory CNS studies and 30 participants in healthy people studies
Aim In this multicenter study a cell-based assay CBA based on cell transfection was proposed to semi-quantitatively detect specific antibodies in human serum samples of study participants with highly suspected clinical manifestations of MOGAD and the control population Each study participant used two CBA detection methods to detect MOG-IgG at the same time namely live cell based and fixed cell based to obtain diagnostic performance parameters and consistency evaluation sensitivity specificity positive predictive value negative predictive value of the two methods and combined with comprehensive clinical diagnosis to compare their clinical diagnostic value To explore the individual assay cutoffs for the diagnosis of MOGAD in China
Total enrollment participants with high clinical suspicion of MOGAD the number of valid positive cases was 150 and control samples were collected including 30 participants in other inflammatory CNS disease studies 30 participants in non-inflammatory CNS studies and 30 participants in healthy people studies
Time frame August 1 2024 to December 1 2025
Study protocol
1 This study intends to include participants with a high likelihood of MOGAD and to simultaneously match a negative control group including inflammatory CNS disease non-inflammatory CNS disease and healthy people Serum samples of the above study participants were detected by CBA method of live cells and fixed cells According to the comprehensive diagnosis results of clinical experts the specificity sensitivity positive predictive value and negative predictive value of the two methods were compared and the clinical consistency of the two methods was obtained
2 According to the comprehensive clinical diagnosis results the consistency of MOG-IgG positive and titer results between active CBA method and fixed CBA method was evaluated
3 According to the comprehensive clinical diagnosis the diagnostic value of MOGAD in different titers of the two methods was evaluated To obtain the best individual assay cutoffs of MOGAD diagnosis in this study and improve the specificity of disease diagnosis
4 The proportion of study participants with high suspicion of MOGAD who were diagnosed with MOGAD was counted and the clinical characteristics of participants in this part of the study were analyzed to explore the correlation between MOG-IgG antibody titers and clinical characteristics treatment regimen clinical course or disease activity
Official Title Evaluation of the diagnostic value of two cell-based assays for MOG-IGG-associated diseases a multicenter paired design observational study Conditions MOG-IgG detection Intervention Treatment Diagnostic Test CBA method of live cells and fixed cells
Aim In this multicenter study a cell-based assay CBA based on cell transfection was proposed to semi-quantitatively detect specific antibodies in human serum samples of study participants with highly suspected clinical manifestations of MOGAD and the control population Each study participant used two CBA detection methods to detect MOG-IgG at the same time namely live cell based and fixed cell based to obtain diagnostic performance parameters and consistency evaluation sensitivity specificity positive predictive value negative predictive value of the two methods and combined with comprehensive clinical diagnosis to compare their clinical diagnostic value To explore the individual assay cutoffs for the diagnosis of MOGAD in China
Total enrollment participants with high clinical suspicion of MOGAD the number of valid positive cases was 150 and control samples were collected including 30 participants in other inflammatory CNS disease studies 30 participants in non-inflammatory CNS studies and 30 participants in healthy people studies
Time frame August 1 2024 to December 1 2025
Study protocol
1 This study intends to include participants with a high likelihood of MOGAD and to simultaneously match a negative control group including inflammatory CNS disease non-inflammatory CNS disease and healthy people Serum samples of the above study participants were detected by CBA method of live cells and fixed cells According to the comprehensive diagnosis results of clinical experts the specificity sensitivity positive predictive value and negative predictive value of the two methods were compared and the clinical consistency of the two methods was obtained
2 According to the comprehensive clinical diagnosis results the consistency of MOG-IgG positive and titer results between active CBA method and fixed CBA method was evaluated
3 According to the comprehensive clinical diagnosis the diagnostic value of MOGAD in different titers of the two methods was evaluated To obtain the best individual assay cutoffs of MOGAD diagnosis in this study and improve the specificity of disease diagnosis
4 The proportion of study participants with high suspicion of MOGAD who were diagnosed with MOGAD was counted and the clinical characteristics of participants in this part of the study were analyzed to explore the correlation between MOG-IgG antibody titers and clinical characteristics treatment regimen clinical course or disease activity
Official Title Evaluation of the diagnostic value of two cell-based assays for MOG-IGG-associated diseases a multicenter paired design observational study Conditions MOG-IgG detection Intervention Treatment Diagnostic Test CBA method of live cells and fixed cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None