Clinical Research Directory

Clinical Outcomes of Stroke in MalIgnanCy

Sponsor: University of L'Aquila

Summary

Title Clinical Outcomes of Stroke in MalIgnanCy (COSMIC). Aims To characterize acute ischemic stroke (AIS) and spontaneous non-traumatic intracerebral hemorrhage (ICH) occurring in patients with current or previous malignancy; to define cancer-, stroke-, imaging-, treatment-, and laboratory-related phenotypes; and to quantify short- and medium-term neurological, vascular, bleeding, functional, and mortality outcomes. Study design Multicenter, observational, prospective real-world registry. No study-mandated therapeutic intervention is assigned. Setting Participating emergency departments, stroke units, neurology departments, neurocritical-care units, oncology/hematology services, and affiliated hospitals. Consecutive eligible cases should be entered at each site to reduce selection bias. Participation is restricted to centers that routinely apply an occult-malignancy screening protocol in patients with cryptogenic ischemic stroke, including at minimum blood testing and total-body CT with or without intravenous contrast, according to local clinical practice and contraindications. Study population Adults (≥18 years) with imaging-confirmed AIS or spontaneous non-traumatic parenchymal ICH and a documented current or previous qualifying malignancy. Basal cell carcinoma and cutaneous squamous cell carcinoma are excluded as qualifying malignancies. Enrollment period Index strokes occurring during the 2-year enrollment period beginning on the date of central ethics committee approval, with standardized follow-up at 90±14 days and 365±30 days. Overall study duration Prospective enrollment will continue for 2 years from the date of central ethics committee approval. Each participant will undergo follow-up at 90±14 days and 365±30 days; therefore, overall study completion will occur after the final enrolled participant completes the 1-year follow-up window, followed by database cleaning and lock. Primary objective To estimate the 1-year cumulative incidence of any recurrent stroke after the index event in patients with malignancy, overall and separately after index AIS and index ICH. Primary endpoint Any recurrent stroke within 1 year, defined as recurrent ischemic stroke and/or new spontaneous non-traumatic ICH occurring after the index event. Hemorrhagic transformation of an ischemic infarct is not counted as recurrent ICH. Key secondary endpoints All-cause mortality and vascular death; ordinal modified Rankin Scale (mRS) and functional dependency; recurrent AIS and recurrent ICH separately; myocardial infarction; venous thromboembolism (VTE); ISTH major extracranial bleeding; net adverse clinical events; seizures; atrial fibrillation detected after stroke (AFDAS); and time-varying cancer status/treatment. Sample size No fixed hypothesis-driven sample size is imposed. COSMIC is an inclusive registry and participating sites will enroll all consecutive eligible patients. Precision and model complexity will be determined by the final number of patients and outcome events. Statistical approach Descriptive analyses; time-to-event and cumulative incidence analyses, accounting for death as a competing event where appropriate; cause-specific Cox and/or Fine-Gray regression models; Kaplan-Meier and Cox proportional hazards analyses for mortality; ordinal regression for functional outcome (mRS); multivariable adjustment for clinically relevant covariates; center-clustered inference; and prespecified subgroup and exploratory analyses. Funding No study-specific funding is assumed in this protocol version; any subsequent funding source will be disclosed in study documents and publications.

Official title: Clinical Outcomes of Stroke in MalIgnanCy (COSMIC)

Key Details

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