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ATROPOS: Assessing morTality and Risk factOrs in Immune checkPoint Inhibitor-induced myotOxicities: a Survival Analysis Based on an International Registry

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hopital Pitie-Salpetriere / CIC-2503
RECRUITING
Paris
Contact Information
Primary
Joe-Elie Salem, MD-PhD
joe-elie.salem@aphp.fr
0033142178531
Time Frame
Start Date: 2026-05-20
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 1500
Related Therapeutic Areas
Sponsors
Leads: Groupe Hospitalier Pitie-Salpetriere
Collaborators: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov

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