Montreal Immune-Related Adverse Events (MIRAE) Study

Immune checkpoint inhibitors (ICI) are among the most promising approaches to fighting cancer. However, a substantial percentage of patients experience off-target adverse effects in the form of mild to severe inflammation in different organs, commonly called immune-related adverse events (irAEs). irAEs can lead to treatment discontinuation, or can be life-threatening in extreme cases. The causes of irAEs are largely unknown and there are no reliable predictive biomarkers. The Montreal Immune-Related Adverse Events (MIRAE) study collects clinical information and biospecimens (blood, tissue, stool) from cancer patients treated with ICI to facilitate research on the identification of predictive biomarkers of irAEs, their causes, and the design of effective management strategies.

NCT Number	NCT05139706
Lead Sponsor	Sir Mortimer B. Davis - Jewish General Hospital
Conditions	Cancer, Immune System Disorder, Inflammatory Reaction, Autoimmune Diseases
Enrollment	1,000 participants
Start Date	2020-01-21
Primary Completion	2030-01 (estimated)
Study Completion	2030-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-03