Car-Te-Cell: Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT05772611
Collaborator
(none)
180
1
84.5
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Genetic and immunology tests

Study Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Feb 15, 2024
Anticipated Study Completion Date :
Feb 15, 2029

Arms and Interventions

Arm Intervention/Treatment
Antibody characterized

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

Biological: Genetic and immunology tests
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.

Atypical

Patients with atypical antibody

Biological: Genetic and immunology tests
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.

Without antibody

Patients without antibody

Biological: Genetic and immunology tests
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient with neurological disorder

  • Patient with antibodies or not in sera or CSF

Exclusion Criteria:
  • No available clinical data

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:
NCT05772611
Other Study ID Numbers:
  • 788
First Posted:
Mar 16, 2023
Last Update Posted:
Mar 16, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2023