Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes

Recruiting

• Conditions: Paraneoplastic Neurological Syndrome; Autoimmune Encephalitis
• Interventions: Biological: Genetic and immunology tests

• Registration Number: NCT05772611
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. Although rare the diagnosis of AE or PNS is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. Autoantibodies highly specific of AE and PNS has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. Their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. However, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect AE or PNS no specific autoantibodies are identified leading frequently to an inappropriate treatment. Furthermore, as the mechanisms of AE and PNS is still unknown, treatments are not optimal and in some cases inefficient. There is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2023-02-14
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Primary Completion: 2024-02-15
• Study Completion: 2029-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patient with neurological disorder
• Patient with antibodies or not in sera or CSF

Exclusion Criteria

• No available clinical data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antibody characterized	Genetic and immunology tests	Patients with well-characterized antibody (HU, YO, RI, CASPR2, NMDAr, GAD, ...)
Without antibody	Genetic and immunology tests	Patients without antibody
Atypical	Genetic and immunology tests	Patients with atypical antibody

Primary Outcome Measures

Name	Time	Method
Correlation between biological results and clinical data	Through study completion, an average of 1year	This measure will compare the result of immunological and genetic makers with clinical data of each patient.

Trial Locations

Locations (1)

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes; 🇫🇷 Lyon, France