ClinicalTrials.gov record NCT05772611
Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes
Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study uses already collected clinical information and stored biological samples from people with suspected autoimmune encephalitis or paraneoplastic neurological syndromes. It analyzes immune and genetic markers and compares those results with each patient's clinical data. Usual diagnostic and treatment care is not changed.
What it is studying. The study aims to characterize immune and genetic findings in people with suspected autoimmune encephalitis or paraneoplastic neurological syndromes and to correlate those biological results with patients' clinical data.
What the researchers hope to learn. To describe and correlate immunological and genetic markers with clinical features in autoimmune encephalitis and paraneoplastic neurological syndromes; to better characterize immune responses in these conditions.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- Genetic and immunology tests
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patient with neurological disorder
- Patient with antibodies or not in sera or CSF
Exclusion criteria
- No available clinical data
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is non‑interventional: researchers will use existing clinical records and stored biological samples (blood, DNA, cerebrospinal fluid, and cells) collected during routine care. Laboratory analyses will include genetic and immunology tests and those results will be compared with each patient's clinical data. Standard diagnostic and treatment care will not be changed. The study uses samples and data already stored with prior written consent for research and genetic analysis.
How the study is structured. Observational, cross-sectional cohort study using existing clinical records and biobanked samples (blood, cerebrospinal fluid, DNA, cells). No experimental treatments are given and standard care is unchanged.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune encephalitis
Important dates
- Study start
- Feb 1, 2022
- Primary completion
- Feb 15, 2024 (estimated)
- Study completion
- Feb 15, 2029 (estimated)
- Target enrollment
- 180 participants (estimated)
- Last updated on registry
- Mar 16, 2023
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Hospices Civils de Lyon
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Jerome HONNORAT, MD 📞 +33 4 72 35 78 06 ✉ jerome.honnorat@chu-lyon.fr
- Marine VILLARD, RCA 📞 +33 4 27 85 54 60 ✉ marine.villard@chu-lyon.fr
Participating sites (1)
- Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunesRecruiting
Lyon, 69677 · France
- Jerome HONNORAT, Pr · 4 72 35 78 06 ext. +33 · jerome.honnorat@chu-lyon.fr
- Jerome HONNORAT, Pr
Terms used on this page · explanations by MedicalUpdates.ai
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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