HLA Analysis in Autoimmune Encephalitis and Related Disorders

Autoimmune Encephalitis Clinical Trial

— ICARE  

Official title:

Immunogenetic Characteristics in Autoimmune Encephalitis and Related Disorders: HLA Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04106596
• Other study ID #: ICARE
• Status: Not yet recruiting
• Start date: October 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2019
• Source: Hospices Civils de Lyon
• Contact: Jerome HONNORAT, PhD
• Phone: 4 72 35 78 08
• Email: jerome.honnorat[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Autoimmune encephalitis (AE) are characterized by subacute onset of memory deficits, altered mental status or psychiatric symptoms, frequently associated with seizures, inflammatory cerebrospinal fluid and in cases with prominent limbic involvement, typical magnetic resonance imaging. Several autoantibodies (Ab) may be detected in AE, although its detection is not mandatory to establish a diagnosis. These Ab mainly recognize different synaptic and cell-surface proteins in the central nervous system, and are thought to be pathogenic as they alter the normal location or function of its antigens.

The primary trigger of the immune response is unknown for most of AE. In addition to acquired susceptibility, genetic predisposition may also be important in the pathogenesis of AE. Human leukocyte antigen (HLA) is the genetic factor most frequently associated with autoimmune diseases, due to its genetic complexity and key role in the adaptive immune response. The aim of the study is to describe HLA profile in three groups of autoimmune encephalitis and related disorders: anti-LGI1, anti-CASPR2 and anti-GAD neurological diseases.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: October 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Presence of anti-LGI1, anti-CASPR2 or anti-GAD antibodies in serum or cerebrospinal fluid;

2. Clinical picture compatible with the detected antibody (limbic encephalitis in anti-LGI1; limbic encephalitis, neuromyotonia or Morvan's syndrome in anti-CASPR2; limbic encephalitis, cerebellar ataxia or stiff-person syndrome in anti-GAD

Exclusion Criteria:

• Absence of complete clinicobiological data.

Related Conditions & MeSH terms

• Ataxia
• Autoimmune Cerebellar Ataxia
• Autoimmune Encephalitis
• Cerebellar Ataxia
• Encephalitis
• Hashimoto Disease
• Imbic Encephalitis
• Stiff-person Syndrome

Locations

Country	Name	City	State
France	Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HLA in autoimmune encephalitis and related disorders	Description of HLA alleles and haplotypes carrier frequencies in autoimmune encephalitis and related disorders	12 Months
Primary	Clinical relevance of HLA in autoimmune encephalitis and related disorders	Description of clinical differences among patients regarding their HLA status	12 Months