Status:
UNKNOWN
JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Conditions:
Myocarditis
Cardiomyopathies
Eligibility:
All Genders
Brief Summary
Immune checkpoint inhibitors (ICIs) might induce high grade immune-related adverse events (irAEs) involving the cardio-vascular system. This study investigates reports of cardio-vascular toxicity asso...
Detailed Description
ICIs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and in combination. Thus, irAEs can occur and risk factors for ...
Eligibility Criteria
Inclusion
- Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2025
- Case reported in the APHP Entrepot de Données de Santé (EDS) database of individual safety case reports to 01/01/2025
- Case reported in the Système National Des Données de Santé (SNDS) Database of individual safety case reports to 01/01/2025
- Case reported in a retrospective international multicenter registry of ICI-associated myocarditis to 01/01/2025
- Adverse event reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)
- Patients treated with ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), Cemiplimab (L01XC33)
Exclusion
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
500000 Patients enrolled
Trial Details
Trial ID
NCT04294771
Start Date
January 1 2019
End Date
January 1 2025
Last Update
September 15 2023
Active Locations (1)
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1
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, France, 75013