ATROPOS: Survival Analysis of ICI-associated Myocarditis

Recruiting now

Conditions studied: Immune Checkpoint Inhibitor-associated Myocarditis

In brief

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.

Key facts

Study ID

NCT07633587

Run by

Groupe Hospitalier Pitie-Salpetriere

People needed

1500

Starts

2026-05-20

Expected to finish

2027-10-01

Last updated by the study team

2026-06-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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• record/patient withdrawn from research use unresolved data-quality issues preventing inclusion in the final SAP-defined analysis set.

Where it is running

• Hopital Pitie-Salpetriere / CIC-2503 — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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