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ATROPOS: Survival Analysis of ICI-associated Myocarditis

Study acronym: ATROPOS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study Status, Eligibilityv2
  2. Minor Study First Submitted
ATROPOS is an international, registry-based observational study of cancer patients with immune checkpoint inhibitor-associated myocarditis (ICI-M). The study evaluates whether immunosuppressive treatment strategies, including first-line glucocorticoids and subsequent second-line immunosuppressants, are associated with overall mortality, and whether these associations vary according to myocarditis severity. The target number of cases to be included is 1500 spanning from at least 160 centers, located in at least 18 countries. Analyses will adjust for clinically relevant confounders and may use time-dependent survival models where appropriate.
Trial Details
NCT Number NCT07633587
Lead Sponsor Groupe Hospitalier Pitie-Salpetriere
Collaborators: Vanderbilt University Medical Center
Conditions
(from sponsor)
Immune Checkpoint Inhibitor-associated Myocarditis
Related terms Myocarditis, Myotoxicity
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov