NCT06617962 Evaluation of Two Cell-based Assays for Diagnosing MOG-IgG Associated Disorders
| NCT ID | NCT06617962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2024-11-18 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Quan Chao
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT06617962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06617962 currently recruiting?
Yes, NCT06617962 is actively recruiting participants. Contact the research team at chao_quan@fudan.edu.cn for enrollment information.
Where is the NCT06617962 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06617962 clinical trial?
NCT06617962 is sponsored by Huashan Hospital. The principal investigator is Quan Chao at Huashan Hospital. The trial plans to enroll 240 participants.