Montreal Immune-Related Adverse Events (MIRAE) Study

NCT05139706 | Recruiting

• 1 other identifier: MP-05-2019-1517
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Immune System Disorder; Inflammatory Reaction; Autoimmune Diseases

Keywords

irAEs; ICI (ICB); CTLA-4; PD-1; PDL-1; Pembrolizumab; Nivolumab; Ipilimumab; Cemiplimab; Atezolizumab; Avelumab; Durvalumab

Outcome Measures

Primary Outcomes (2)

• Incidence of immune-related adverse events

  Up to 5 years

• Biomarkers of irAE

  Up to 5 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients treated with ICI, patients with primary autoimmune or autoinflammatory diseases and healthy volunteers.

You may qualify if:

• \>= 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

You may not qualify if:

• Participants not able to provide informed consent

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Whole blood * Peripheral blood mononuclear cells * Stool * Tissue biopsies

MeSH Terms

Conditions

Neoplasms; Immune System Diseases; Inflammation; Autoimmune Diseases; Diabetes Mellitus, Insulin-Dependent, 12

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Hudson, MD

  Jewish General Hospital, McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Hudson, MD

CONTACT

1-514-340-8222; marie.hudson@mcgill.ca, marie.hudson.med@ssss.gouv.qc.ca

Manuel Flores, PhD

CONTACT

1-514-677-8155; Manuel.Flores.Molina.ccomtl@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marie Hudson, MD MPH FRCPC Principal Investigator, Rheumatologist, Division of Rheumatology and Department of Medicine, Jewish General Hospital and McGill University

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: January 21, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 3, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)