RecruitingNCT05139706

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


Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Enrollment

1,000 participants

Start Date

Jan 21, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

  • \>= 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 Criteria1

  • Participants not able to provide informed consent

Locations(1)

Jewish General Hospital

Montreal, Quebec, Canada

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NCT05139706


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