NCT05969379

Investigational Biomarkers for Neurological Immune-related Adverse Events

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurological Disease

Interventions

Type	Name	Description
GENETIC	Analysis of biomarkers and their correlation with clinical characteristics and outcome	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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2023-08-01
• Last updated: 2023-08-01

Locations

1 site across 1 country: France