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Evaluation of Two Cell-based Assays for Diagnosing MOG-IgG Associated Disorders

Evaluation of the diagnostic value of two cell-based assays for MOG-IGG-associated diseases: a multicenter, paired design observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092371
Enrollment
Unknown
Registered
2024-11-14
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelin oligodendrocyte glycoprotein antibody-associated disease

Interventions

Gold Standard:Diagnosis of myelin oligodendrocyte glycoprotein antibody-associated disease: International MOGAD Panel proposed criteria
Index test:Live cell based assay and fixed cell based assay to detect MOG-IgG

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age =18 years old, male and female. 2.MOGAD is highly suspected. 3.Other inflammatory CNS disease control groups include: According to the diagnostic criteria and consensus of various diseases, the diagnosis of multiple sclerosis, Autoimmune encephalitis (except NMDAR encephalitis), Guillain-Barre syndrome (GBS), Chronic Inflammatory Demyelinating polyradiculopathy (CIDP), Retinal Cerebrovascular disease (SUSAC), POEMS syndrome (POEMS), and neuropathy were confirmed. The monoclonal gammopathy of unknown significance (MGUS), Sarcoidosis and so on. 4.The control group of non-inflammatory central nervous system diseases included: Migraine, CSVD, benign cranial hypertension, Glioma with definite diagnosis and no other autoimmune diseases. 5.Healthy controls include healthy people who have no autoimmune diseases through physical examination and other means. 6.Complete clinical data. 7.Informed consent of the patient or his guardian has been obtained.

Exclusion criteria

Exclusion criteria: 1.According to the Guidelines for Diagnosis and Treatment of Optic Neuromyelitis Spectrum Diseases (2021), patients with optic Neuromyelitis Spectrum diseases (NMOSD) with positive AQP4 were clearly diagnosed. 2.According to the Expert Consensus on the Diagnosis and Treatment of Autoimmune encephalitis in China (2022), the diagnosis was confirmed as NMDAR encephalitis. 3.Patients with positive anti-glial fibrillary acidic protein antibody (GFAP-IgG) in serum and/or cerebrospinal fluid. 4.Lack of clinical data. 5.Unqualified blood samples. 6.The patient's informed consent was not obtained. 7.Misdiagnosis in the research process went wrong in this study.

Design outcomes

Secondary

MeasureTime frame
Clinical features of participanrs;

Primary

MeasureTime frame
Outcome of two CBA detection methods;

Countries

China

Contacts

Public ContactChao Quan

Huashan Hospital, Fudan University

drquanchao@163.com+86 21 52887151

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026