NCT05139706 Montreal Immune-Related Adverse Events (MIRAE) Study
| NCT ID | NCT05139706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2020-01-21 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2020-01-21 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Marie Hudson, MD
PRINCIPAL INVESTIGATOR
Jewish General Hospital, McGill University
Frequently Asked Questions
Who can join the NCT05139706 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05139706 currently recruiting?
Yes, NCT05139706 is actively recruiting participants. Contact the research team at marie.hudson@mcgill.ca, marie.hudson.med@ssss.gouv.qc.ca for enrollment information.
Where is the NCT05139706 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05139706 clinical trial?
NCT05139706 is sponsored by Sir Mortimer B. Davis - Jewish General Hospital. The principal investigator is Marie Hudson, MD at Jewish General Hospital, McGill University. The trial plans to enroll 1,000 participants.
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