Clinical trial · Observational
Montreal Immune-Related Adverse Events (MIRAE) Study
Montreal Database and Biorepository of Cancer Patients Treated With Immune Checkpoint Inhibitors for the Study of Immune-related Adverse Events
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Diseases | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Immune System Disorder | — | UNRESOLVED | — |
| Inflammatory Reaction | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Incidence of immune-related adverse events
- timeFrame
- Up to 5 years
- measure
- Biomarkers of irAE
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available