Montreal Immune-Related Adverse Events (MIRAE) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorSir Mortimer B. Davis - Jewish General Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
>= 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
Disqualifiers
Participants not able to provide informed consent
Trial population
Cancer patients treated with ICI, patients with primary autoimmune or autoinflammatory diseases and healthy volunteers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of immune-related adverse events
Time frame
Up to 5 years2
Biomarkers of irAE
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov