[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449993":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":23,"responsibleParty":43,"collaborators":7,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":60,"studyType":61,"phases":7,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Sir Mortimer B. Davis - Jewish General Hospital","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Marie Hudson, MD","Jewish General Hospital, McGill University","PRINCIPAL_INVESTIGATOR",[14,19],{"name":10,"role":15,"phone":16,"phoneExt":17,"email":18},"CONTACT","1-514-340-8222","23476","marie.hudson@mcgill.ca, marie.hudson.med@ssss.gouv.qc.ca",{"name":20,"role":15,"phone":21,"phoneExt":7,"email":22},"Manuel Flores, PhD","1-514-677-8155","Manuel.Flores.Molina.ccomtl@ssss.gouv.qc.ca",[24],{"facility":25,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Jewish General Hospital","RECRUITING","Montreal","Quebec","H3T 1E2","Canada","CA",{"type":33,"coordinates":34},"Point",[35,36],-73.58781,45.50884,{"lat":36,"lon":35},[39,42],{"name":40,"role":15,"phone":16,"phoneExt":17,"email":41},"Marie Hudson, MD MPH","marie.hudson@mcgill.ca",{"name":20,"role":15,"phone":21,"phoneExt":7,"email":22},{"type":12,"investigatorFullName":10,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Marie Hudson, MD MPH FRCPC Principal Investigator, Rheumatologist, Division of Rheumatology and Department of Medicine, Jewish General Hospital and McGill University","100449993","montreal-immune-related-adverse-events-mirae-study-100449993",false,"NCT05139706","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","MIRAE","Inclusion Criteria:\n\n* \\>= 18 years of age\n* cancer patients treated with ICI therapy (e.g., anti-CTLA-4, anti-PD-1, anti-PD-L1, and combinations)\n* patients with primary autoimmune or autoinflammatory diseases that resemble immune-related adverse events (irAEs)\n* healthy volunteers with non-inflammatory disorders, and without any history of cancer\n\nExclusion Criteria:\n\n* Participants not able to provide informed consent",true,"ALL","18 Years","100 Years",{"count":58,"type":59},1000,"ESTIMATED","60 Months","OBSERVATIONAL","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.",[64,65,66,67],"Cancer","Immune System Disorder","Inflammatory Reaction","Autoimmune Diseases",[69,70,71,72,73,74,75,76,77,78,79,80],"irAEs","ICI (ICB)","CTLA-4","PD-1","PDL-1","Pembrolizumab","Nivolumab","Ipilimumab","Cemiplimab","Atezolizumab","Avelumab","Durvalumab","2026-01-30",{"date":83,"type":84},"2026-02-03","ACTUAL",{"date":86,"type":84},"2020-01-21",{"date":88,"type":59},"2030-01",{"name":5,"class":6},1]