Evaluating two methods for diagnosing MOG-antibody related disorders
Evaluation of The Diagnostic Value of Two Cell-based Assays for MOG-IgG-associated Diseases: A Multicenter, Paired Design Observational Study
Huashan Hospital · NCT06617962
This study is testing two different lab methods to see which one is better at diagnosing MOG-antibody related disorders in people who might have them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Huashan Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06617962 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the diagnostic performance of two cell-based assays for detecting MOG-IgG in patients suspected of having MOG-antibody related disorders (MOGAD). It involves collecting serum samples from participants with high clinical suspicion of MOGAD and control groups, including individuals with other inflammatory CNS diseases, non-inflammatory CNS diseases, and healthy controls. The study will assess the sensitivity, specificity, and overall clinical diagnostic value of both live cell-based and fixed cell-based assays to determine the most effective method for diagnosing MOGAD in a Chinese population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a high clinical suspicion of MOGAD.
Not a fit: Patients with confirmed diagnoses of other autoimmune diseases unrelated to MOGAD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing MOGAD, leading to better patient management and treatment outcomes.
How similar studies have performed: While this approach is novel in the context of MOGAD, similar methodologies have shown promise in diagnosing other autoimmune disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Healthy controls include healthy people who have no autoimmune diseases through physical examination and other means. * Complete clinical data. * Informed consent of the patient or his guardian has been obtained. Exclusion Criteria: * 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. * Unqualified blood samples. * The patient\'s informed consent was not obtained. * Misdiagnosis in the research process went wrong in this study.
Where this trial is running
Shanghai, Shanghai Municipality
- Huashan Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Quan Chao — Huashan Hospital
- Study coordinator: Chao Quan
- Email: chao_quan@fudan.edu.cn
- Phone: 86 13651957283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myelin Oligodendrocyte Glycoprotein-Antibody Related Disorders