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 trea
| Condition(s) | Cancer, Immune System Disorder, Inflammatory Reaction, Autoimmune Diseases |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Sir Mortimer B. Davis - Jewish General Hospital |
| Locations | Montreal, Quebec, Canada |
| Start date | 2020-01-21 |
| NCT ID | NCT05139706 |
| Official listing | https://clinicaltrials.gov/study/NCT05139706 |