NCT05728931

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
70mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jan 2022Jan 2032

Study Start

First participant enrolled

January 15, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2032

Expected
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

November 21, 2022

Last Update Submit

February 12, 2023

Conditions

Keywords

Paraneoplastic Neurological SyndromeAutoimmune Encephalitis

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System DiseasesAutoimmune DiseasesImmune System Diseases

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

Locations