Actively Recruiting
Evaluation of Two Cell-based Assays for Diagnosing MOG-IgG Associated Disorders
Led by Huashan Hospital · Updated on 2025-10-01
240
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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, any gender.
- High clinical suspicion of MOG-IgG-associated disorder (MOGAD).
- Diagnosis of other inflammatory CNS diseases including multiple sclerosis, autoimmune encephalitis (except NMDAR encephalitis), Guillain-Barre syndrome, chronic inflammatory demyelinating polyradiculopathy, retinal cerebrovascular disease, POEMS syndrome, neuropathy, monoclonal gammopathy of unknown significance, sarcoidosis.
- Diagnosis of non-inflammatory CNS diseases, including migraine, cerebral small vessel disease, benign cranial hypertension, glioma without autoimmune diseases.
- Healthy individuals with no autoimmune diseases confirmed by physical exam or other means.
- Complete clinical data available.
- Informed consent obtained from patient or guardian.
You will not qualify if you...
- Diagnosis of optic neuromyelitis spectrum diseases with positive AQP4.
- Diagnosis of NMDAR encephalitis.
- Positive anti-glial fibrillary acidic protein antibody (GFAP-IgG) in serum or cerebrospinal fluid.
- Incomplete clinical data.
- Unqualified blood samples.
- Informed consent not obtained.
- Misdiagnosis during the study process.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
C
Chao Quan
CONTACT
J
Jingzi Zhangbao
CONTACT
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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