Montreal Database and Biorepository of Cancer Patients Treated With Immune Checkpoint Inhibitors for the Study of Immune-related Adverse Events

What this Trial Is About

Immune checkpoint inhibitors (ICI) are promising treatments for cancer by activating the immune system to attack tumors. However, many patients experience immune-related adverse events (irAEs), which are inflammatory reactions affecting various organs and can range from mild to severe or life-threatening. The causes of these irAEs are not well understood, and there are currently no reliable biomarkers to predict who will develop them. The Montreal Immune-Related Adverse Events (MIRAE) study aims to collect clinical data and biological samples from cancer patients treated with ICIs to help identify these biomarkers and understand irAEs better. The study involves collecting various samples such as blood, tissue, stool, plasma, PBMCs, and saliva from patients undergoing treatment with different types of ICIs, including CTLA-4, PD-1, and PD-L1 inhibitors. It also includes patients with autoimmune or autoinflammatory diseases resembling irAEs, as well as healthy volunteers without cancer. The study gathers detailed clinical information alongside these samples to support research on predicting and managing irAEs and investigating how treatments for irAEs affect tumor biology. Participants will be involved for up to five years, during which researchers will monitor the incidence of immune-related adverse events and study related biomarkers. The study tracks how immunomodulatory treatments impact both irAEs and cancer outcomes. Data and samples collected will support long-term research to find better ways to minimize irAEs while maximizing the effectiveness of immune checkpoint inhibitors.

Montreal Immune-Related Adverse Events (MIRAE) Study