Actively Recruiting
Evaluation of The Diagnostic Value of Two Cell-based Assays for MOG-IgG-associated Diseases: A Multicenter, Paired Design Observational Study
Led by Huashan Hospital · Updated on 2025-10-01
240
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate two cell-based assays for diagnosing Myelin Oligodendrocyte Glycoprotein-IgG-associated disorders (MOGAD), a rare inflammatory autoimmune disease. The study focuses on comparing live-cell and fixed-cell assay methods to detect MOG-IgG antibodies in Chinese patients highly suspected of having MOGAD. It also seeks to validate these diagnostic methods in a real-world, multicenter setting and determine the best assay cutoffs for accurate diagnosis in China. Participants include those with a strong clinical suspicion of MOGAD and control groups with other inflammatory CNS diseases, non-inflammatory CNS diseases, and healthy individuals. Serum samples from all participants are tested using both live-cell and fixed-cell based CBA (cell-based assay) methods. The study gathers data to assess and compare the sensitivity, specificity, predictive values, and diagnostic consistency of the two assays, following established diagnostic criteria and expert clinical diagnoses. Participants provide serum samples and clinical data that researchers use to analyze the correlation between MOG-IgG antibody levels and clinical features such as treatment, disease course, and activity. The study runs from August 1, 2024, to December 1, 2025, with ongoing evaluation of diagnostic performance parameters. Researchers monitor diagnostic accuracy and clinical characteristics to improve detection and diagnosis of MOGAD in the study population.
CONDITIONS
Brief Title
Evaluation of Two Cell-based Assays for Diagnosing MOG-IgG Associated Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male and female
- High suspicion of MOG-IgG-associated disorder (MOGAD)
- Diagnosis of other inflammatory CNS diseases including multiple sclerosis, autoimmune encephalitis (excluding NMDAR encephalitis), Guillain-Barre syndrome, chronic inflammatory demyelinating polyradiculopathy, retinal cerebrovascular disease, POEMS syndrome, neuropathy, monoclonal gammopathy of unknown significance, sarcoidosis, and others
- Diagnosis of non-inflammatory CNS diseases including migraine, cerebral small vessel disease, benign cranial hypertension, glioma with no autoimmune diseases
- Healthy individuals with no autoimmune diseases confirmed by physical examination
- Complete clinical data available
- Informed consent obtained from patient or guardian
You will not qualify if you...
- Diagnosed with optic Neuromyelitis Spectrum diseases (NMOSD) with positive AQP4 antibody
- Diagnosed with NMDAR encephalitis
- Positive for anti-glial fibrillary acidic protein antibody (GFAP-IgG) in serum or cerebrospinal fluid
- Missing clinical data
- Unqualified blood samples
- Lack of informed consent
- Misdiagnosis during the research process
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 months
Participants provide serum samples that are tested using two cell-based assays to detect MOG-IgG antibodies and evaluate diagnostic performance.
1 visit (sample collection)
Duration - Up to 16 months
Participants’ diagnostic results are analyzed along with clinical data to assess diagnostic value and correlation with clinical characteristics.
No additional visits required
Trial Site Locations
Total: 1 location
1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
C
Chao Quan
J
Jingzi Zhangbao
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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