Evaluating two methods for diagnosing MOG-antibody related disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.