Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorMonash University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients aged 40 years and older with melanoma of any stage, who are planned for, currently receiving or have received treatment with an ICI may be considered for this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.
The change in non-calcified coronary plaque volume will be measured on serial computed tomography coronary angiography scans.
Time frame
18 monthsSecondary outcomes
1
To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.
Time frame
18 months2
To determine the relationship between statin use and the burden, composition and progression of coronary atherosclerosis in individuals with melanoma treated with ICIs.
The change in non-calcified coronary plaque volume as measured on serial computed tomography coronary angiography scans will be compared between patients treated with statins and patients not treated with statins in the study.
Time frame
18 months3
To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs.
The number of patients who were started on statin therapy by their treating clinicians after undergoing computed tomography coronary angiography in the study will be recorded.
Time frame
18 months4
To evaluate the impact of participation in a cardio-oncology trial on measures of quality of life in patients with melanoma treated with ICIs.
Quality of life will be assessed by using the PHQ-9, GAD-7, EORTC QLQ-C30, EuroQOL EQ-5D, and FACT-M questionnaires at baseline and at 18 month follow up. The change in quality of life scores on each questionnaire will be compared with historical cohorts that have previously been reported in the literature.
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Monash University
Lead sponsor
National Health and Medical Research Council, Australia
Collaborator
Source ClinicalTrials.gov