Autoimmune EncephalitisCar-Te-CellNCT05772611
Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes
An observational study of Autoimmune Encephalitis and Paraneoplastic Neurological Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Encephalitis, Paraneoplastic Neurological Syndrome
- What is being tested?
- Genetic and immunology tests
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 15 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with auto-immune encephalitis suspected and antibody characterized or not.
Who may be able to join
- Patient with neurological disorder
- Patient with antibodies or not in sera or CSF
Who cannot join
- No available clinical data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Lyon, 69677
Jerome HONNORAT, Pr, 4 72 35 78 06 ext. +33, jerome.honnorat@chu-lyon.fr
Jerome HONNORAT, Pr
About this study
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.
- Being tested
- Genetic and immunology tests
- Keywords
- autoimmune encephalitis, paraneoplastic neurological syndromes, genetic
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic and immunology testsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Antibody characterized | Patients with well-characterized antibody (HU, YO, RI, CASPR2, NMDAr, GAD, …) Receives: Biological: Genetic and immunology tests | |
| Atypical | Patients with atypical antibody Receives: Biological: Genetic and immunology tests | |
| Without antibody | Patients without antibody Receives: Biological: Genetic and immunology tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between biological results and clinical data
This measure will compare the result of immunological and genetic makers with clinical data of each patient.
Measured: Through study completion, an average of 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Feb 2022
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772611
- Sponsor's protocol ID
- 788
- Acronym
- Car-Te-Cell
- Status last verified
- Mar 2023
- First submitted
- 14 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes
- ClinicalTrials.gov ID
- NCT05772611
- Acronym / sponsor ID
- Car-Te-Cell / 788
- Keywords
- autoimmune encephalitis, paraneoplastic neurological syndromes, genetic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antibody characterized | – | Biological: Genetic and immunology testsPatients with well-characterized antibody (HU, YO, RI, CASPR2, NMDAr, GAD, …) |
| Atypical | – | Biological: Genetic and immunology testsPatients with atypical antibody |
| Without antibody | – | Biological: Genetic and immunology testsPatients without antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with auto-immune encephalitis suspected and antibody characterized or not.
Key inclusion criteria (2 listed)
- Patient with neurological disorder
- Patient with antibodies or not in sera or CSF
Key exclusion criteria (1 listed)
- No available clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic and immunology testsThis 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. | Biological | Antibody characterized, Atypical, Without antibody |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis and Paraneoplastic Neurological Syndrome, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerome HONNORAT, MD (+33 4 72 35 78 06, jerome.honnorat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between biological results and clinical data (time frame: Through study completion, an average of 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.