ATROPOS: Survival Analysis of ICI-associated Myocarditis
ATROPOS: Assessing morTality and Risk factOrs in Immune checkPoint Inhibitor-induced myotOxicities: a Survival Analysis Based on an International Registry
Groupe Hospitalier Pitie-Salpetriere
1,500 participants
May 20, 2026
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- cancer patients exposed to at least one immune checkpoint inhibitor
- possible, probable or definite immune checkpoint inhibitor-associated myocarditis recorded in the international registry according to registry/adjudication definitions
- available index-date/presentation information
- available mortality follow-up.
Exclusion Criteria3
- duplicate records
- not enough data to classify as myocarditis
- record/patient withdrawn from research use unresolved data-quality issues preventing inclusion in the final SAP-defined analysis set.
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07633587