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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05180942
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Monash University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Stephen J Nicholls, MBBS, PhD
Principal Investigator Affiliation	Monash University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Atherosclerosis

Contact a Trial Team

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