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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

"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."

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Paris, Frankrig
        • Rekruttering
        • Hopital Pitie-Salpetriere / CIC-2503
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause mortality at 90 days after ICI-M presentation/index date
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause mortality at 30 days and 360 days after ICI-M presentation/index date
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Samarbejdspartnere

Vanderbilt University Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIC2503-26-06 (Registry Identifier: REDCap International ICI-myocarditis registry)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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