ClinicalTrials.gov record NCT04698421

Collection of Biological Samples From Patients With Rare Neurological Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Prospective Collection of Biological Samples From Patients With Rare Neurological Diseases

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age6 years old to 99 years old
SexAll
LocationFrance
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 collects biological samples and clinical data from people with rare neurological disorders that have a known or suspected autoimmune cause. Samples (mainly blood) and linked clinical information will be stored and made available to researchers to look for new autoantibodies and biomarkers. Participants are followed from enrollment with samples taken at baseline and during about one year of follow-up.

What it is studying. The study is building a collection of blood samples and clinical data to identify new diagnostic and prognostic autoantibodies and other biomarkers, to profile patients' blood immune cells and genes, and to explore disease mechanisms (including work using animal models) that may inform future research.

What the researchers hope to learn. Build a biobank of clinical data and biological samples from patients with rare autoimmune neurological disorders; identify new autoantibodies; discover biomarkers related to disease severity to inform future therapeutic research; profile immune cells and patient genes; study pathophysiological mechanisms using animal models.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The aim of this project is to improve biological collections of patients presenting rare neurological disorders with known or suspected autoimmune origin. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Biological
  • Blood collection on admission and longitudinally

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • all patients with neurological disorders, with known or probable autoimmune involvement. This includes adults and children and peripheral and/or central nervous system symptoms.
  • Social coverage up to date.

Exclusion criteria

  • Patients with neurological damage from which the autoimmune character can be excluded.
  • Known anemia and hemoglobin <10 g / dl
  • Patients under protective supervision (guardianship, curators)
  • Pregnant or breastfeeding woman

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Neuroimmunology is a rapidly expanding field since major advances have been made in basic immunology and numerous new clinical entities have been identified in the last 10 years. Even if these discoveries have led to major advances in patient's management and treatment, a lot of work needs to be done to improve the diagnosis and prognostic biomarkers. It is widely known that the immune system is implicated in a variety of neurological disorders such as infections, encephalitis or multiple sclerosis. Numerous neurological disorders affecting the central and peripheral nervous system can be attributed to the immune system and need to be recognized as some of them can be cured by appropriate immunotherapy. These neurological disorders include autoimmune encephalitis and paraneoplastic neurological syndromes but also myasthenia, chronic demyelinating inflammatory polyneuropathy and other neuromuscular pathologies. These neurological disorders are characterized by the presence of autoantibodies in the patient's sera or cerebral spinal fluid (CSF). These autoantibodies are generally highly specific and necessary to make the diagnosis. However, in some cases, despite strong clinical arguments for a neuroimmunological disorder, we do not identify autoantibodies, leading to inappropriate treatment and a blind follow-up considering the risk of recurrence or of associated tumor. Furthermore, even if the specific role of some autoantibodies or of immune T cells in some of these pathologies are suspected or already documented, for most of them the exact mechanism is still unknown. We need to explore the sera and CSF of these patients to identify new diagnosis and prognosis biomarker. Moreover, the availability of immune cells isolated from these patients will help us to decipher the pathophysiological mechanisms to create new therapeutic strategies. For this, animal models are already available in Centre Physiopathology Toulouse and in the French reference center in Lyon. As genetic susceptibilities may underlie, at least in part, the variability of the clinical manifestations and of the response to treatment, DNA from patients will be collected and immune genes sequencing will be compared to other control groups, included international database.

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.

Provide blood samples at enrollment (Day 0) and at follow-up visits over the study period (about one year). At some visits a larger blood draw will be taken (the record specifies 8 tubes of 7 mL). Collected samples and clinical data will be stored and used for laboratory analyses such as searching for autoantibodies, immune-cell profiling, and gene sequencing related to immune responses.

How the study is structured. A prospective observational cohort. Participants provide blood samples and clinical information at enrollment (Day 0) and over the study period (about one year). No experimental treatment is assigned; samples and data are collected and stored for research analyses.

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

Clinical trials40 trials listed for autoimmune encephalitisEvery trial the registry lists for autoimmune encephalitis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune encephalitis researchLatest monthly update: September 2026. Includes: Efgartigimod reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 12, 2020
Primary completion
Jan 1, 2030 (estimated)
Study completion
Sep 3, 2030 (estimated)
Target enrollment
1000 participants (estimated)
Last updated on registry
Mar 19, 2026
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
University Hospital, Toulouse

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.

Participating sites (1)

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.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

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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