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RecruitingNCT05772611Car-Te-CellUpdated Mar 16, 2023

Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes

An observational study in Autoimmune Encephalitis and Paraneoplastic Neurological Syndrome, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by Hospices Civils de Lyon · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2022; still recruiting 4 years 9 months later.

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
180
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 22 studies in Autoimmune Diseases of the Nervous System by Hospices Civils de Lyon — 8 open to participants now, 11 under way, none of them phase 3. Autoimmune Diseases of the Nervous System · Hospices Civils de Lyon.

Planned enrollment
8th of 21
180 · median 50
Started
2022
with 4 others
Observational
21 of 22
7 open now
Primary completion
2024-02
later than 3 of 10 live
Registered
12th of 22
by date

Among the 22 studies in Autoimmune Diseases of the Nervous System by Hospices Civils de Lyon, this one is the 8th largest by planned enrollment of the 21 observational ones that give a count, is one of 5 that started in 2022, is one of 21 observational ones, reaches primary completion later than 3 of the 10 other live ones, and was the 12th registered.

Autoimmune Diseases of the Nervous System

123 studies on the registry are indexed under Autoimmune Diseases of the Nervous System; 59 are open to participants now.

Browse Autoimmune Diseases of the Nervous System studies →

Open to participants now

8 of the 22 studies in Autoimmune Diseases of the Nervous System by Hospices Civils de Lyon are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 44 Autoimmune Diseases of the Nervous System studies recruiting now, 27 (61%) set no upper age limit and 11 (25%) stop at 75 or younger; 15 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Autoimmune Encephalitis
  • Paraneoplastic Neurological Syndrome

Keywords

  • autoimmune encephalitis
  • paraneoplastic neurological syndromes
  • genetic
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with auto-immune encephalitis suspected and antibody characterized or not.

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Inclusion criteria

  • Patient with neurological disorder
  • Patient with antibodies or not in sera or CSF

Exclusion criteria

Exclusion Criteria:

  • No available clinical data
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
180 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Antibody characterized

    Patients with well-characterized antibody (HU, YO, RI, CASPR2, NMDAr, GAD, ...)

    Biological: Genetic and immunology tests

  • Atypical

    Patients with atypical antibody

    Biological: Genetic and immunology tests

  • Without antibody

    Patients without antibody

    Biological: Genetic and immunology tests

Interventions

  • BiologicalGenetic and immunology tests

    This is a non-interventional study involving clinical data and biological samples (blood, DNA, CSF, cells). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes.

06

What researchers measure

Primary outcomes

  1. Correlation between biological results and clinical data

    This measure will compare the result of immunological and genetic makers with clinical data of each patient.

    Time frame: Through study completion, an average of 1year

07

Study locations

1 of 1 sites recruiting
  • Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
    Lyon, 69677, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2022 (actual). Primary completion is estimated for Feb 2024, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2023
First posted
Mar 16, 2023
StartActual
Feb 1, 2022
Primary completionEst.
Feb 15, 2024
CompletionEst.
Feb 15, 2029
Last update
Mar 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05772611
Responsible party
Sponsor
First posted
Mar 16, 2023
Start date
Feb 1, 2022
Primary completion
Feb 15, 2024 (estimated)
Completion
Feb 15, 2029 (estimated)
Last update
Mar 16, 2023

Study contacts

Jerome HONNORAT, MD
Contact
jerome.honnorat@chu-lyon.fr
+33 4 72 35 78 06
Marine VILLARD, RCA
Contact
marine.villard@chu-lyon.fr
+33 4 27 85 54 60

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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