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OpenTrials
Active, Not Recruiting

NCT Number: NCT05728931

New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes

Lyon, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria * :
  • patient with neurological disorder
  • patient without antibody
  • Exclusion Criteria * :
  • patient with characterized antibody
  • patient without neurological disorder

Treatment and study plan

Test of biological samples

Biological

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

Primary outcomes

  1. Description of new biomarkers

    Time frame: Baseline

    Results of diagnostics tests for each patient, description of marking

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: DeNobio

Important dates

Study start
2022
Primary completion
2026
Study completion
2032
First posted
Feb 15, 2023
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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