Genetic Predisposition, Inflammation, and Neurodegeneration Biomarkers in Patients With Neurological Adverse Events of Immune Checkpoint Inhibitors: Correlation With Clinical Phenotypes and Outcome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neurological Disease
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Analysis of neurofilaments
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of n-irAEs
Exclusion Criteria
- •Presence of an alternative diagnosis explaining the neurological syndrome
Outcomes
Primary Outcomes
Analysis of neurofilaments
Time Frame: 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.