Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Recruiting now
Conditions studied: Melanoma, Atherosclerosis
In brief
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.
Key facts
- Study ID
- NCT05180942
- Run by
- Monash University
- People needed
- 130
- Starts
- 2022-11-07
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-08-27
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Nepean Hospital — Kingswood, New South Wales, Australia (enrolling)
- Calvary Mater Newcastle — Waratah, New South Wales, Australia (enrolling)
- Bundaberg Base Hospital — Bundaberg, Queensland, Australia (enrolling)
- Hervey Bay Hospital — Hervey Bay, Queensland, Australia (enrolling)
- Ipswich Hospital — Ipswich, Queensland, Australia (enrolling)
- Toowoomba Hospital — Toowoomba, Queensland, Australia (enrolling)
- Queen Elizabeth Hospital — Woodville South, South Australia, Australia (enrolling)
- Monash Health — Clayton, Victoria, Australia (enrolling)
- Peninsula Health — Frankston, Victoria, Australia (enrolling)
- Cabrini Health — Malvern, Victoria, Australia (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
- Mildura Public Base Hospital — Mildura, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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