Clinical trial NCT05180942: Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Official title: Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Atherosclerosis
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2022-01-06
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: 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

Primary outcomes:
measure: To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.
timeFrame: 18 months
Secondary outcomes:
measure: To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.
timeFrame: 18 months
measure: To determine the relationship between statin use and the burden, composition and progression of coronary atherosclerosis in individuals with melanoma treated with ICIs.
timeFrame: 18 months
measure: To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs.
timeFrame: 18 months
measure: To evaluate the impact of participation in a cardio-oncology trial on measures of quality of life in patients with melanoma treated with ICIs.
timeFrame: 18 months
measure: To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs.
timeFrame: 18 months
measure: To determine progression free survival with regard to the underlying melanoma following treatment with ICIs.
timeFrame: 18 months
measure: To determine overall survival in patients with melanoma treated with ICIs.
timeFrame: 18 months
Other outcomes:
Locations:
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Ipswich
country: Australia
facility: Ipswich Hospital
state: Queensland
city: Woodville South
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Health
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Mildura
country: Australia
facility: Mildura Public Base Hospital
state: Victoria
Study officials:
affiliation: Monash University
name: Stephen J Nicholls, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: