Evaluation of Two Cell-based Assays for Diagnosing MOG-IgG Associated Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHuashan Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age ≥18 years old, male and female.
MOGAD is highly suspected.
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.
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.
Disqualifiers
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.
According to the Expert Consensus on the Diagnosis and Treatment of Autoimmune encephalitis in China (2022), the diagnosis was confirmed as NMDAR encephalitis.
Patients with positive anti-glial fibrillary acidic protein antibody (GFAP-IgG) in serum and/or cerebrospinal fluid.
Lack of clinical data.
Trial population
Individual medical units plan to collect serum samples from clinically suspected MOGAD study participants (150 valid positive cases will be the cutoff for sample collection) between September 2024 and December 2024.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
CBA method of live cells and fixed cells
Diagnostic test1. Study participants with high clinical suspicion of MOGAD: 2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples. Sensitivity, specificity, positive predictive value and negative predictive value of the two detection methods were calculated according to the detection results and combined with the 2023 MOGAD diagnostic criteria. 2. Control group：2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Study participants with high clinical suspicion of MOGAD1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
diagnostic performance parameters and consistency evaluation
Each study participant used two cell-based assays to detect MOG-IgG simultaneously, namely live cell based and fixed cell based, to obtain the diagnostic performance parameters and consistency evaluation (sensitivity, specificity, positive predictive value, negative predictive value) of the two methodologies.
Time frame
August 1, 2024 to December 1, 2025.Sponsors and contacts
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Source ClinicalTrials.gov