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Recruiting Not applicable

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

NCT06865274 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-02-20
Last updated
2025-03-07

Condition(s) studied

Neuromyelitis Optica Spectrum DisordersMOGADMultiple Sclerosis

Investigational drug(s) / intervention(s)

Blood draw for the laboratory assessment

Blood draw for the laboratory assessment: Blood draw of approximately 5 ml of peripheral venous blood (collected in EDTA) will be collected for DNA extraction and genetic analysis limited to the research of FCG3A polymorphisms

Study summary

The goal of this study is to assess the frequency of genetic polymorphisms of the FCG3A in a cohort of Italian patients affected by neuromyelitis optica spectrum disorder (NMOSD) and mog antibody associated disease (MOGAD) and in a a comparison group of patients affected with Multiple Sclerosis (MS).

The study will involve adult patients diagnosed with MS, NMOSD, or MOGAD, followed at various clinical centers in the Lazio region.

Patients from the participating clinical centers will be selected, and their medical records will be analyzed to collect clinical and neuroimaging data. The data will include demographic information such as age, sex and body mass index and clinical information such as age at disease onset, disease duration, antibody status (AQP4+/- and MOG+/-), disease-modifying therapies, as well as MRI data and the Expanded Disability Status Scale (EDSS) score.

Each patient included in the study will undergo a single blood draw of approximately 5 ml of peripheral venous blood during routine blood tests, which will be used for DNA extraction and polimorphysm analysis. Demographic and clinical differences between patients with NMOSD and MOGAD, with and without the polymorphism, will be assessed and compared with the group of patients with MS.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients diagnosed with MS, NMOSD, or MOGAD receiving care at participating centers * Patients aged ≥ 18 years * Ability to understand and sign informed consent Exclusion Criteria: * Individuals under 18 years of age * Inability to provide informed consent

Primary outcome measure(s)

  • FCGR3A gene polymorphism frequency in a cohort of Italian patients affected by NMOSD and MOGAD. — Baseline
    To assess the frequency of the FCGR3A gene polymorphism in a cohort of Italian patients affected by NMOSD and MOGAD.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Roma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06865274 on ClinicalTrials.gov ↗ ← All trials in Italy