Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
About this study
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.
- Condition
- Melanoma, Atherosclerosis
- Sponsor
- Monash University
Who can join
- Age
- 40 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 40 years
- Study condition: Melanoma, Atherosclerosis
- 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 9
- 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
12 sites, 12 recruiting
Bundaberg Base Hospital
Bundaberg, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Peninsula Health
Frankston, Victoria, Australia
Hervey Bay Hospital
Hervey Bay, Queensland, Australia
Ipswich Hospital
Ipswich, Queensland, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
and 6 more sites on ClinicalTrials.gov
Contact
-
Domenic Sacca
+61 (0) 423245187 domenic.sacca@monash.edu
Potential match only. Final eligibility is determined by the study team.