Investigational Biomarkers for Neurological Immune-related Adverse Events (NFL-ICI)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Neurological Disease

Treatments: Genetic: Analysis of biomarkers and their correlation with clinical characteristics and outcome

Study type: Observational

Funder types: Other

Identifiers

NCT05969379

69HCL23_0712

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of n-irAEs

Exclusion criteria

• Presence of an alternative diagnosis explaining the neurological syndrome

Trial design

80 participants in 1 patient group

Patients with neurological immune-related adverse events (n-irAEs)

Description:

Patients developing neurological syndromes related to administration of any immune checkpoint inhibitors, including central nervous system disorders and neuromuscular toxicties

Treatment:

Genetic: Analysis of biomarkers and their correlation with clinical characteristics and outcome