Actively Recruiting
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Led by Monash University · Updated on 2025-08-27
130
Participants Needed
12
Research Sites
186 weeks
Total Duration
On this page
Sponsors
M
Monash University
Lead Sponsor
N
National Health and Medical Research Council, Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of providing informed consent and willing to follow all study requirements
- Age 40 years or older
- Histologically confirmed melanoma of any stage planned for, started, or completed treatment with immune checkpoint inhibitors
- Imaging quality acceptable as judged by the core laboratory
- Investigator believes participant will follow all protocol requirements including follow-up CTCA scans
You will not qualify if you...
- Known clinically manifest cardiovascular disease
- Female participants who are pregnant, breastfeeding, or planning pregnancy during the study
- Estimated kidney function (eGFR) less than 45 mL/min
- Severe liver disease or cirrhosis
- History of any other cancer within the past 5 years besides melanoma, except non-melanoma skin cancers
- Expected survival less than 18 months due to prognostic factors such as unresectable brain metastases
- Any other significant non-cardiac disease or condition that would prevent participation as judged by the Investigator
- Major allergy to iodine
- Participation in another clinical trial that disallows multiple trial participation at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
2
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
3
Bundaberg Base Hospital
Bundaberg, Queensland, Australia, 4670
Actively Recruiting
4
Hervey Bay Hospital
Hervey Bay, Queensland, Australia, 4655
Actively Recruiting
5
Ipswich Hospital
Ipswich, Queensland, Australia, 4305
Actively Recruiting
6
Toowoomba Hospital
Toowoomba, Queensland, Australia, 4350
Actively Recruiting
7
Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Actively Recruiting
8
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
9
Peninsula Health
Frankston, Victoria, Australia, 3199
Actively Recruiting
10
Cabrini Health
Malvern, Victoria, Australia, 3144
Actively Recruiting
11
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3051
Actively Recruiting
12
Mildura Public Base Hospital
Mildura, Victoria, Australia, 3500
Actively Recruiting
Research Team
D
Domenic Sacca
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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