Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
NCT ID: NCT05180942
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
130 participants
OBSERVATIONAL
2022-11-07
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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National Health and Medical Research Council, Australia
OTHER
Monash University
OTHER
Responsible Party
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Stephen Nicholls
Professor
Principal Investigators
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Stephen J Nicholls, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Monash University
Locations
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Ipswich Hospital
Ipswich, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Peninsula Health
Frankston, Victoria, Australia
Cabrini Health
Malvern, Victoria, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Bundaberg Base Hospital
Bundaberg, Queensland, Australia
Hervey Bay Hospital
Hervey Bay, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Mildura Public Base Hospital
Mildura, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Lisa Smith
Role: primary
Other Identifiers
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SOCRATES
Identifier Type: -
Identifier Source: org_study_id
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