Neuropathy and Anti-GFAP Antibodies (Neuro-GFAP)

Study of the Consequences of Anti-GFAP Antibodies on the Peripheral Nervous System

Anti-Glial Fibrillary Acidic Protein (GFAP) are antibodies associated to inflammatory diseases of the central nervous system. The GFAP protein is highly expressed by astrocytes explaining these syndromes, but GFAP is also expressed by immature and non-myelinating Schwann cells. Thus, these antibodies could also lead to damages of the peripheral nervous system (PNS). Moreover, such damages have already been reported on small studies, and there is a need for larger cohorts.

The investigators will use the cohort of patients with neurological syndromes and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Reference center for paraneoplastic neurological syndromes and autoimmune encephalitis" to determine the frequency of the PNS involvement in these patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Neurological Diseases or Conditions; Neurological Diseases Associated to Anti GFAP Antibodies
• Intervention / Treatment: Other: Clinical examination; Other: electroneuromyography (ENMG)

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69677
    • Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

120 patients presenting with neurological symptoms and with identified anti-GFAP antibodies in the CSF, included in the French cohort of patients with neurological syndroms and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes", will be studied.

Description

Inclusion Criteria:

• - Age > 18 years old
• Neurological symptoms
• Anti-GFAP antibodies identified in the CSF

Exclusion Criteria:

• - Uncomplete data in the medical records of patients

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients presenting with neurological symptoms and anti-GFAP antibodies in the CSF.; This is a non-interventional study involving biological samples. Samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "iological Resource Center of the Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids). The group will be composed of patients included in the French cohort of patients with neurological syndromes and anti-GFAP antibodies in the CSF.

Other: Clinical examination; The examination performed by the clinician of the patient will be analyzed from the cohort as previously explained.; Other: electroneuromyography (ENMG); Data from the ENMGs will be extracted from the cohort and analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cranial nerves abnormality at clinical examination of abnormal ENMG	Data concerning the clinical examination and the ENMG will be extracted from the cohort of patients with neurological syndroms and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes".	Immediately after diagnosis

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Estimate): February 23, 2023

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: neuropathy; GFAP
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 22-5018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No