Investigational Biomarkers for Neurological Immune-related Adverse Events

NCT05969379 | Unknown

• 1 other identifier: 69HCL23_0712
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Disease

Keywords

Biomarkers; autoimmunity; immunotherapy side-effects; immune checkpoint inhibitors; neuroimmunology

Outcome Measures

Primary Outcomes (1)

• Analysis 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.

  At enrollment

Study Arms (1)

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

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

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

Interventions

Analysis of biomarkers and their correlation with clinical characteristics and outcome GENETIC

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at least 18 years-old with a diagnosis of n-irAE

You may qualify if:

• Clinical diagnosis of n-irAEs

You may not qualify if:

• Presence of an alternative diagnosis explaining the neurological syndrome

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Hôpital neurologique Pierre Wertheimer

Bron, 69500, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma EDTA, whole blood, CSF, PBMC

MeSH Terms

Conditions

Nervous System Diseases; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

FR (1)