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JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors

Study acronym: JOCARDITE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Jan 1, 2025 to Jan 1, 2030v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v3
  4. Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 8 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 associated with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase, Assistance Publique Hopitaux de Paris Entrepot de Données de Santé (APHP.EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis
Trial Details
NCT Number NCT04294771
Lead Sponsor Groupe Hospitalier Pitie-Salpetriere
Conditions
(from sponsor)		 Myocarditis, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases, Pericarditis, Vasculitis
Related terms Cardiomyopathies, Cardiovascular Diseases, Heart Diseases, Myocarditis, Pericarditis, Vasculitis
Enrollment 500,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov