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

NCT05772611 | Recruiting

• 1 other identifier: 788
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Encephalitis; Paraneoplastic Neurological Syndrome

Keywords

autoimmune encephalitis; paraneoplastic neurological syndromes; genetic

Outcome Measures

Primary Outcomes (1)

• Correlation between biological results and clinical data

  This measure will compare the result of immunological and genetic makers with clinical data of each patient.

  Through study completion, an average of 1year

Study Arms (3)

Antibody characterized

Patients with well-characterized antibody (HU, YO, RI, CASPR2, NMDAr, GAD, …)

Biological: Genetic and immunology tests

Atypical

Patients with atypical antibody

Biological: Genetic and immunology tests

Without antibody

Patients without antibody

Biological: Genetic and immunology tests

Interventions

Genetic and immunology tests BIOLOGICAL

This is a non-interventional study involving clinical data and biological samples (blood, DNA, CSF, cells). Clinical data are collected for the center and 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 "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes.

Antibody characterized; Atypical; Without antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with auto-immune encephalitis suspected and antibody characterized or not.

You may qualify if:

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

You may not qualify if:

• \- No available clinical data

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes

Lyon, 69677, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, DNA, cells, CSF collected at diagnosis time

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Interventions

Immunologic Tests

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Central Study Contacts

Jerome HONNORAT, MD

CONTACT

+33 4 72 35 78 06; jerome.honnorat@chu-lyon.fr

Marine VILLARD, RCA

CONTACT

+33 4 27 85 54 60; marine.villard@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 16, 2023
• Study Start: February 1, 2022
• Primary Completion: February 15, 2024
• Study Completion (Estimated): February 15, 2029
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

FR (1)