RecruitingNCT05180942

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


Sponsor

Monash University

Enrollment

130 participants

Start Date

Nov 7, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 40 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

Locations(12)

Nepean Hospital

Kingswood, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Bundaberg Base Hospital

Bundaberg, Queensland, Australia

Hervey Bay Hospital

Hervey Bay, Queensland, Australia

Ipswich Hospital

Ipswich, Queensland, Australia

Toowoomba Hospital

Toowoomba, Queensland, Australia

Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

Peninsula Health

Frankston, Victoria, Australia

Cabrini Health

Malvern, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Mildura Public Base Hospital

Mildura, Victoria, Australia

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NCT05180942


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