Multicenter Prospective Interventional Study Evaluating FCGR3A Gene Polymorphisms in Neuromyelitis Optica Spectrum Disorders, MOG Antibody Disease, and Multiple Sclerosis

What this Trial Is About

Researchers are studying the frequency of a specific genetic variation, the FCGR3A-V158F polymorphism, in adult Italian patients diagnosed with neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), and Multiple Sclerosis (MS). The study aims to understand how this genetic variation may relate to these neurological conditions and compare clinical features among affected patients. The research involves patients followed at various clinical centers in the Lazio region. Participants will have a single peripheral venous blood draw of about 5 ml during routine blood tests. This blood will be used for DNA extraction and analysis of the FCGR3A gene polymorphisms. The study includes two groups: patients with NMOSD or MOGAD, and a comparison group with MS. Genetic testing will be conducted at a specialized genomic medicine section, with DNA samples stored anonymously for up to 10 years. During the study, researchers will review medical records to collect demographics, clinical history, antibody status, therapies, MRI data, and disability scores. The main outcome is the frequency of the FCGR3A polymorphism at baseline. Secondary outcomes include any clinical differences between patients with or without the polymorphism over 24 months. Participation involves data collection, consent for genetic testing, and follow-up through medical record review. The total study duration is 24 months with a 12-month enrollment period.

Frequency of FCGR3A Gene Polymorphisms in Patients With Neuromyelitis Optica Spectrum Disorders, Anti-oligodendrocyte Myelin Protein Antibody Disease, and Multiple Sclerosis.