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Collection of Biological Samples from Patients with Rare Neurological Diseases

NCT ID: NCT04698421

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-12

Study Completion Date

2030-09-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nervous System Diseases

Keywords

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autoimmune encephalitis paraneoplastic neurological syndrome myasthenia paraneoplastic cerebellar degeneration rare neuropathologies with known/suspected autoimmune origin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with rare autoimmune neurological diseases

Blood collection on admission and longitudinally

Intervention Type BIOLOGICAL

Biological samples will be collected in the normal diagnosis and follow-up process. Only blood will be taken in larger quantity (8 tubes of 7mL).

Interventions

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Blood collection on admission and longitudinally

Biological samples will be collected in the normal diagnosis and follow-up process. Only blood will be taken in larger quantity (8 tubes of 7mL).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chloé Bost, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Purpan University Hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Chloé Bost, PharmD, PhD

Role: CONTACT

Phone: 5 61 77 61 44

Email: [email protected]

Facility Contacts

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Chloé Bost, PharmD, PhD

Role: primary

Other Identifiers

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RC31/20/0150

Identifier Type: -

Identifier Source: org_study_id