Collecting data on immune-related side effects in cancer treatment
Montreal Database and Biorepository of Cancer Patients Treated With Immune Checkpoint Inhibitors for the Study of Immune-related Adverse Events
This study is trying to collect information and samples from cancer patients using immune treatments to see what causes side effects and how to better manage them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05139706 on ClinicalTrials.gov |
What this trial studies
The Montreal Immune-Related Adverse Events (MIRAE) study aims to gather clinical information and biological samples from cancer patients undergoing treatment with immune checkpoint inhibitors (ICIs). This observational study focuses on understanding the causes and identifying predictive biomarkers for immune-related adverse events (irAEs), which can range from mild to severe and may lead to treatment discontinuation. By analyzing these samples, researchers hope to develop effective management strategies for irAEs and improve patient outcomes in cancer therapy.
Who should consider this trial
Good fit: Ideal candidates include cancer patients aged 18 and older who are being treated with immune checkpoint inhibitors.
Not a fit: Patients who are unable to provide informed consent or those without a history of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and management of immune-related adverse events in cancer patients, enhancing their treatment experience and outcomes.
How similar studies have performed: While the study addresses a significant issue in cancer treatment, the approach of identifying biomarkers for irAEs is still relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec
- Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Marie Hudson, MD — Jewish General Hospital, McGill University
- Study coordinator: Marie Hudson, MD
- Email: marie.hudson@mcgill.ca, marie.hudson.med@ssss.gouv.qc.ca
- Phone: 1-514-340-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.