Recruiting NCT05180942

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

— Observational Melanoma Atherosclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Melanoma, Atherosclerosis. Basic parameters: from 40 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Australia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs. [Time frame: 18 months]

Secondary outcome measures (7)

To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs. [Time frame: 18 months]
To determine the relationship between statin use and the burden, composition and progression of coronary atherosclerosis in individuals with melanoma treated with ICIs. [Time frame: 18 months]
To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs. [Time frame: 18 months]
To evaluate the impact of participation in a cardio-oncology trial on measures of quality of life in patients with melanoma treated with ICIs. [Time frame: 18 months]
To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs. [Time frame: 18 months]
To determine progression free survival with regard to the underlying melanoma following treatment with ICIs. [Time frame: 18 months]
To determine overall survival in patients with melanoma treated with ICIs. [Time frame: 18 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Australia · 12 centers

Nepean Hospital — Kingswood
Calvary Mater Newcastle — Waratah
Bundaberg Base Hospital — Bundaberg
Hervey Bay Hospital — Hervey Bay
Ipswich Hospital — Ipswich
Toowoomba Hospital — Toowoomba
Queen Elizabeth Hospital — Woodville South
Monash Health — Clayton
… and 4 more centers

Identifiers

NCT: NCT05180942 · SOCRATES

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗