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

NCT ID: NCT05180942

Last Updated: 2025-08-27

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-07

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role lead

Responsible Party

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Stephen Nicholls

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Toowoomba Hospital

Toowoomba, Queensland, Australia

Site Status RECRUITING

Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Site Status RECRUITING

Monash Health

Clayton, Victoria, Australia

Site Status RECRUITING

Peninsula Health

Frankston, Victoria, Australia

Site Status RECRUITING

Cabrini Health

Malvern, Victoria, Australia

Site Status RECRUITING

Nepean Hospital

Kingswood, New South Wales, Australia

Site Status RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Site Status RECRUITING

Bundaberg Base Hospital

Bundaberg, Queensland, Australia

Site Status RECRUITING

Hervey Bay Hospital

Hervey Bay, Queensland, Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

Mildura Public Base Hospital

Mildura, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Domenic Sacca

Role: CONTACT

+61 (0) 423245187

Facility Contacts

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Prakash Dhopte

Role: primary

Joshua Bennetts

Role: primary

Darren Nicholls

Role: primary

Darren Nicholls

Role: primary

Lisa Smith

Role: primary

Kerry Blacket

Role: primary

Pamela Cooper

Role: primary

Mary-Anne Austin

Role: primary

Judith Reilly

Role: primary

Demis Balamatsias

Role: primary

Caroline Suhr

Role: primary

Gemma Madigan

Role: primary

Other Identifiers

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SOCRATES

Identifier Type: -

Identifier Source: org_study_id

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