Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Recruiting · NCT05180942 · Observational (researchers observe without assigning treatment) · Lead sponsor: Monash University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
12 locations listed.
- 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