- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05772611
Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes (Car-Te-Cell)
March 6, 2023 updated by: Hospices Civils de Lyon
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jerome HONNORAT, MD
- Phone Number: +33 4 72 35 78 06
- Email: jerome.honnorat@chu-lyon.fr
Study Contact Backup
- Name: Marine VILLARD, RCA
- Phone Number: +33 4 27 85 54 60
- Email: marine.villard@chu-lyon.fr
Study Locations
-
-
-
Lyon, France, 69677
- Recruiting
- Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
-
Contact:
- Jerome HONNORAT, Pr
- Phone Number: +33 4 72 35 78 06
- Email: jerome.honnorat@chu-lyon.fr
-
Principal Investigator:
- Jerome HONNORAT, Pr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with auto-immune encephalitis suspected and antibody characterized or not.
Description
Inclusion Criteria:
- Patient with neurological disorder
- Patient with antibodies or not in sera or CSF
Exclusion Criteria:
- No available clinical data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Antibody characterized
Patients with well-characterized antibody (HU, YO, RI, CASPR2, NMDAr, GAD, …)
|
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.
|
Atypical
Patients with atypical antibody
|
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.
|
Without antibody
Patients without antibody
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between biological results and clinical data
Time Frame: Through study completion, an average of 1year
|
This measure will compare the result of immunological and genetic makers with clinical data of each patient.
|
Through study completion, an average of 1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Anticipated)
February 15, 2024
Study Completion (Anticipated)
February 15, 2029
Study Registration Dates
First Submitted
February 14, 2023
First Submitted That Met QC Criteria
March 6, 2023
First Posted (Actual)
March 16, 2023
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 6, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 788
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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