New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes

Active, not recruiting

• Conditions: Paraneoplastic Neurological Syndrome; Autoimmune Encephalitis

• Registration Number: NCT05728931
• 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-15
• Study First Submitted: 2022-11-21
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-12
• Last Update Submitted: 2023-02-12
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15
• Primary Completion: 2026-01-15
• Study Completion: 2032-01-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of new biomarkers	Baseline	Results of diagnostics tests for each patient, description of marking

Trial Locations

Locations (1)

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