DeNobio: New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05728931

Collaborator

(none)

210

Enrollment

Location

120

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Paraneoplastic Neurological Syndrome Autoimmune Encephalitis	Biological: Test of biological samples

Study Design

Study Type:

Observational

Anticipated Enrollment :

210 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes

Actual Study Start Date :

Jan 15, 2022

Anticipated Primary Completion Date :

Jan 15, 2026

Anticipated Study Completion Date :

Jan 15, 2032

Outcome Measures

Primary Outcome Measures

Description of new biomarkers [Baseline]
Results of diagnostics tests for each patient, description of marking

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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:

NCT05728931

Other Study ID Numbers:

First Posted:

Feb 15, 2023

Last Update Posted:

Feb 15, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Paraneoplastic Neurological Syndrome

Autoimmune Encephalitis

Additional relevant MeSH terms:

Paraneoplastic Syndromes

Encephalitis

Syndrome

Study Results

No Results Posted as of Feb 15, 2023