Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

ATROPOS: Survival Analysis of ICI-associated Myocarditis (ATROPOS)

8 juin 2026 mis à jour par: Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Immune Checkpoint Inhibitor-associated Myocarditis

Description détaillée

"ATROPOS (Assessing lethaliTy and Risk factOrs in immune checkPoint inhibitors-induced myOcardia survival analysis based on an international registry) is an observational, non-interventional analysis of the international REDCap registry of immune checkpoint inhibitor-associated myocarditis (ICI-M).

The study population consists of cancer patients exposed to immune checkpoint inhibitors and recorded in the registry with possible, probable, or definite ICI-M according to registry/adjudication definitions. The main objective is to evaluate associations between immunosuppressive treatment strategies and overall mortality, as a function of myocarditis severity, focusing on first-line glucocorticoids and the subsequent use of second-line immunosuppressants. The study will also assess whether these associations are modified by myocarditis severity. Secondary analyses will examine mortality at 30, 90 and 360 days, cause-specific death (e.g. myotoxicity, cancer-related) where available, and clinical risk factors related to oncology history, ICI exposure, symptoms, ECG, echocardiography, cardiac MRI, biomarkers including CK and troponin, other immune-related adverse events, heart failure, respiratory muscle failure, arrhythmias and conductive disorders, sepsis, and pharmacological treatments.

The statistical approach will include descriptive analyses and Cox proportional-hazards modelling. Time-dependent covariates will be considered for variables such as troponin, left ventricular ejection fraction, severity/grade of the myocarditis/myotoxicity, glucocorticoids and other immunosuppressants. Missing data will be described and handled through prespecified methods, with MICE and JointAI used to cross-check robustness of results. Because treatment strategies are not assigned by the protocol, all treatment-effect analyses will be interpreted as observational associations, adjusted for prespecified clinical confounders.

ATROPOS does not assign study treatment, change patient management, require extra visits, or involve a study drug/device. The central analysis dataset uses coded or pseudonymised data, with direct identifiers retained only by local sites when applicable under their own governance."

Type d'étude

Observationnel

Inscription (Estimé)

1500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Joe-Elie Salem, MD-PhD
Numéro de téléphone: 0033142178531
E-mail: joe-elie.salem@aphp.fr

Lieux d'étude

France
- - Paris, France
    - Recrutement
    - Hopital Pitie-Salpetriere / CIC-2503
    - Contact:
      
      Joe-Elie Salem, MD-PhD
      
      Numéro de téléphone: 0033142178531
      
      E-mail: joe-elie.salem@aphp.fr

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
All-cause mortality at 90 days after ICI-M presentation/index date Délai: 90 days from 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.	90 days from ICI-M presentation/index date

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
All-cause mortality at 30 days and 360 days after ICI-M presentation/index date Délai: 30 days and 360 days from 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.	30 days and 360 days from ICI-M presentation/index date
Modification of treatment-mortality association by myocarditis severity Délai: Up to 360 days from ICI-M presentation/index date	Interaction/sensitivity analyses evaluating whether myocarditis severity modifies the association between glucocorticoid or not and second-line immunosuppressive strategies and mortality outcomes.	Up to 360 days from ICI-M presentation/index date

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Groupe Hospitalier Pitie-Salpetriere

Collaborateurs

Vanderbilt University Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 mai 2026

Achèvement primaire (Estimé)

1 octobre 2027

Achèvement de l'étude (Estimé)

1 octobre 2027

Dates d'inscription aux études

Première soumission

2 juin 2026

Première soumission répondant aux critères de contrôle qualité