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Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS

Recruiting
40 years of age
Both
Phase N/A

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Overview

This study is a prospective observational study evaluating the natural history of coronary plaque burden in participants with melanoma treated with ICI. The study will be conducted at various sites across Australia.

Eligibility

Inclusion Criteria:

  • Capable of providing informed consent and willing to adhere to all protocol requirements
  • patients aged > or equal to 40 years
  • Histologically confirmed melanoma of any stage planned for, commenced, or completed treatment with ICI
  • having acceptable imaging quality deemed by the core laboratory
  • Investigator believes that the participant is willing to adhere to all protocol requirements, including returning for follow up CTCA.

Exclusion Criteria:

  • Known clinically manifest cardiovascular disease
  • Female participants must not be pregnant, breastfeeding or plan to become pregnant during the study.
  • Estimated glomerular filtration rate of <45 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
  • Severe liver disease or cirrhosis
  • History of any other malignancy within the past 5 years in addition to melanoma with the exception of non-melanoma skin cancers
  • Prognostic factors associated with an expected survival less than 18 months at Investigators' discretion (e.g. unresectable brain metastases)
  • Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study
  • Major allergy to iodine
  • Participation in another clinical trial that does not allow participation in multiple trials at the same time

Study details

Melanoma, Atherosclerosis

NCT05180942

Monash University

21 April 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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