New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes
DeNobio
1 other identifier
observational
210
1 country
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2022
CompletedFirst Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2032
ExpectedFebruary 15, 2023
February 1, 2023
4 years
November 21, 2022
February 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Description of new biomarkers
Results of diagnostics tests for each patient, description of marking
Baseline
Interventions
Different tests can be use on biological sample : western bloc, dot blot, immune-fluorescence, immunoprecipitation, CBA, functional test, epitope research, IgG title
Eligibility Criteria
Patient without antibodies known with neurological disorder and include in biobank of "centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes".
You may qualify if:
- patient with neurological disorder
- patient without antibody
You may not qualify if:
- patient with characterized antibody
- patient without neurological disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Lyon, 69677, France
Biospecimen
Blood samples (0.5ml), CSF cerebrospinal Fluid (0.2ml), buffy coat (0.5ml), cells or tumors (FFPE block) have been collected in SNP collection
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2022
First Posted
February 15, 2023
Study Start
January 15, 2022
Primary Completion
January 15, 2026
Study Completion (Estimated)
January 15, 2032
Last Updated
February 15, 2023
Record last verified: 2023-02