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ATROPOS: Survival Analysis of ICI-associated Myocarditis

Recruitingn/aAges any - anyAllGroupe Hospitalier Pitie-Salpetriere
NCT07633587 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * duplicate records * not enough data to classify as myocarditis * record/patient withdrawn from research use unresolved data-quality issues preventing inclusion in the final SAP-defined analysis set.
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What it tests

  • Not listed
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Where

1 site
Hopital Pitie-Salpetriere / CIC-2503
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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