Investigational Biomarkers for Neurological Immune-related Adverse Events
- Conditions
- Neurological Disease
- Interventions
- Genetic: Analysis of biomarkers and their correlation with clinical characteristics and outcome
- Registration Number
- NCT05969379
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Neurological immune-related adverse events (n-irAEs) are an emerging group of disorders of patients with cancer treated with immune checkpoint inhibitors, presenting with heterogeneous clinical manifestations and of uncertain outcome. Novel genetic, inflammatory, and neurogenerative biomarkers could be associated with distinct phenotypes and different outcomes. To test this hypothesis, the study will provide: a phenotypic characterization and outcome assessment of patients with n-irAEs; the analysis of biomarkers of genetic predisposition (HLA and other immunity-related genes), inflammation (serum and cerebrospinal fluid \[CSF\] cytokines and autoantibodies, peripheral blood and CSF lymphocytes and other immune cells, neuroimaging), neurodegeneration (serum and CSF neurofilaments, neuroimaging) and their correlation with clinical features and outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Clinical diagnosis of n-irAEs
- Presence of an alternative diagnosis explaining the neurological syndrome
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with neurological immune-related adverse events (n-irAEs) Analysis of biomarkers and their correlation with clinical characteristics and outcome Patients developing neurological syndromes related to administration of any immune checkpoint inhibitors, including central nervous system disorders and neuromuscular toxicties
- Primary Outcome Measures
Name Time Method Analysis of neurofilaments At enrollment Neurofilaments will be analysed by MSD.
Meso Scale Discovery Electrochemiluminescence (MSD) uses sandwich enzyme-linked immunosorbent assay (ELISA) method coupled with electro¬chemiluminescence (ECL) detection and plate array technology to provide highly sensitive and multiplexed detection of the analytes of interest (like neurofilaments) in a complex biological matrix.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Hôpital neurologique Pierre Wertheimer
🇫🇷Bron, France