Montreal Immune-Related Adverse Events (MIRAE) Study

NCT05139706 · tracked via the Priya Life Science Canada tracker

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Phase

Observational

Started

2020-01-21

Last updated

2026-02-03

Condition(s) studied

CancerImmune System DisorderInflammatory ReactionAutoimmune Diseases

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

Accepted

Inclusion Criteria: * \>= 18 years of age * cancer patients treated with ICI therapy (e.g., anti-CTLA-4, anti-PD-1, anti-PD-L1, and combinations) * patients with primary autoimmune or autoinflammatory diseases that resemble immune-related adverse events (irAEs) * healthy volunteers with non-inflammatory disorders, and without any history of cancer Exclusion Criteria: * Participants not able to provide informed consent

Primary outcome measure(s)

Incidence of immune-related adverse events — Up to 5 years
Biomarkers of irAE — Up to 5 years

Trial sites (1)

Facility	City	Region	Status
Jewish General Hospital	Montreal	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05139706 on ClinicalTrials.gov ↗ ← All trials in Canada