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.
Study Type
OBSERVATIONAL
Enrollment
80
This is a non-interventional study involving clinical data, neuroimaging analysis, and biological samples. Demographics and clinical data are collected in the database of the French Reference Centre. Additional or missing data will be obtained by contacting the referral physicians. All the neuroimages available will be analysed by dedicated software. Samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids). Additional samples for genetic testing will be collected upon explicit written consent.
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Hôpital neurologique Pierre Wertheimer
Bron, France
RECRUITINGAnalysis of neurofilaments
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.
Time frame: At enrollment
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