New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes

Autoimmune Encephalitis Clinical Trial

— DeNobio  

Official title:

New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05728931
• Other study ID #: 748
• Status: Active, not recruiting
• Start date: January 15, 2022
• Est. completion date: January 15, 2032

Study information

• Verified date: February 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. The investigators will use this project to better characterize AE and PNS patients to identify new diagnostic and prognostic biomarkers and develop new diagnostic tools.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: January 15, 2032
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• Inclusion Criteria * :

• patient with neurological disorder

• patient without antibody

• Exclusion Criteria * :

• patient with characterized antibody

• patient without neurological disorder

Related Conditions & MeSH terms

• Autoimmune Encephalitis
• Encephalitis
• Paraneoplastic Neurological Syndrome
• Paraneoplastic Syndromes
• Syndrome

Intervention

Biological:
• Test of biological samples
Different tests can be use on biological sample : western bloc, dot blot, immune-fluorescence, immunoprecipitation, CBA, functional test, epitope research, IgG title

Locations

Country	Name	City	State
France	Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes	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	Description of new biomarkers	Results of diagnostics tests for each patient, description of marking	Baseline