Viewing Study NCT04463550



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Last Modification Date: 2024-10-26 @ 1:39 PM
Study NCT ID: NCT04463550
Status: UNKNOWN
Last Update Posted: 2020-07-09
First Post: 2020-04-17

Brief Title: GFAP Auto-immunity a French Cohort Study
Sponsor: Hospices Civils de Lyon
Organization: Hospices Civils de Lyon

Study Overview

Official Title: GFAP Auto-immunity a French Cohort Study
Status: UNKNOWN
Status Verified Date: 2020-06
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GFAP
Brief Summary: Glial fibrillary acidic protein GFAP-Immunoglobulin G IgG have recently been described as a biomarker of a novel inflammatory central nervous system CNS disorder termed autoimmune GFAP astrocytopathy Thus far four major clinical series have been published two from Mayo Clinic USA one from Italy and one from China GFAP-IgG detected in serum or in cerebrospinal fluid by tissue-based assay and confirmed by cell-based assay are associated with encephalitis or meningoencephalitis of acute or subacute onset less frequently with myelitis or optic disk edema The characteristic MRI feature is brain linear perivascular radial gadolinium enhancement in the white matter perpendicular to the ventricle consistent with the immunohistochemical staining pattern of GFAP in rodent brain sections Approximately 20 of reported cases are associated with a neoplasm ovarian teratoma mostly Coexisting neural autoantibodies are described in some patients N-methyl-D-aspartate NMDA-receptor R-IgG mostly followed by aquaporin 4 AQP4-IgG The disease is usually corticosteroid responsive although relapse can occur In contrast Chinese patients display poorer outcomes Pathophysiology is not well understood but the intracellular antigen location makes GFAP-IgG unlikely pathogenic whereas animal models and neuropathologic data suggest a T-cell immune-mediated disorder

The aim of the investigators is to report the first French cohort of patients GFAP-IgG positive Investigators retrospectively assessed clinical immunological and radiological features treatment response and outcomes
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None