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
This trial does not accept healthy volunteersQualifiers
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record/patient withdrawn from research use unresolved data-quality issues preventing inclusion in the final SAP-defined analysis set.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 population
Cancer patients exposed to immune checkpoint inhibitors and recorded in a REDCap international ICI-Myocarditis registry, including cases with clinical, biomarker, ECG, imaging, treatment, complication and mortality/outcome data sufficient for the planned survival analyses.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
All-cause mortality at 90 days after ICI-M presentation/index date
Death from any cause within 90 days of ICI-M presentation/index date, analysed in relation to immunosuppressive treatment strategy and adjusted for prespecified confounders. Treatment and selected clinical variables may be handled as time-dependent covariates.
Time frame
90 days from ICI-M presentation/index dateSecondary outcomes
1
All-cause mortality at 30 days and 360 days after ICI-M presentation/index date
Mortality (with cause-specific approach) at early and longer follow-up horizons; compare overall and sensitivity models across imputation approaches, handling of competitive risks and time-dependent-covariate strategies.
Time frame
30 days and 360 days from ICI-M presentation/index date2
Modification of treatment-mortality association by myocarditis severity
Interaction/sensitivity analyses evaluating whether myocarditis severity modifies the association between glucocorticoid or not and second-line immunosuppressive strategies and mortality outcomes.
Time frame
Up to 360 days from ICI-M presentation/index dateSponsors and contacts
Click on the lead sponsor to view all of their trials.
Groupe Hospitalier Pitie-Salpetriere
Lead sponsor
Vanderbilt University Medical Center
Collaborator
Source ClinicalTrials.gov