ATROPOS: Survival Analysis of ICI-associated Myocarditis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGroupe Hospitalier Pitie-Salpetriere
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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record/patient withdrawn from research use unresolved data-quality issues preventing inclusion in the final SAP-defined analysis set.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Groupe Hospitalier Pitie-Salpetriere
Lead sponsor
Vanderbilt University Medical Center
Collaborator
Source ClinicalTrials.gov