Neuro-GFAP: Neuropathy and Anti-GFAP Antibodies

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05742087

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neurological Diseases or Conditions Neurological Diseases Associated to Anti GFAP Antibodies	Other: Clinical examination Other: electroneuromyography (ENMG)

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2022

Actual Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Cranial nerves abnormality at clinical examination of abnormal ENMG [Immediately after diagnosis]
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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes	Lyon		France	69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT05742087

Other Study ID Numbers:

22-5018

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

GFAP

neuropathy

Additional relevant MeSH terms:

Nervous System Diseases

Study Results

No Results Posted as of Feb 23, 2023