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Investigational Biomarkers for Neurological Immune-related Adverse Events — NFL-ICI  

Neurological Disease Clinical Trial

Official title:
Genetic Predisposition, Inflammation, and Neurodegeneration Biomarkers in Patients With Neurological Adverse Events of Immune Checkpoint Inhibitors: Correlation With Clinical Phenotypes and Outcome

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05969379
Study type Observational
Source Hospices Civils de Lyon
Contact
Status Recruiting
Phase
Start date May 1, 2022
Completion date December 1, 2023
View Details
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