Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
SOCRATES
1 other identifier
observational
130
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2022
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2022
CompletedStudy Start
First participant enrolled
November 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
August 27, 2025
August 1, 2025
3.6 years
November 11, 2021
August 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.
The change in non-calcified coronary plaque volume will be measured on serial computed tomography coronary angiography scans.
18 months
Secondary Outcomes (7)
To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.
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.
18 months
To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs.
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.
18 months
To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs.
18 months
- +2 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Bundaberg Base Hospital
Bundaberg, Queensland, 4670, Australia
Hervey Bay Hospital
Hervey Bay, Queensland, 4655, Australia
Ipswich Hospital
Ipswich, Queensland, 4305, Australia
Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Peninsula Health
Frankston, Victoria, 3199, Australia
Cabrini Health
Malvern, Victoria, 3144, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3051, Australia
Mildura Public Base Hospital
Mildura, Victoria, 3500, Australia
Biospecimen
Optional blood samples will be collected for Future Biomedical Research
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen J Nicholls, MBBS, PhD
Monash University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 11, 2021
First Posted
January 6, 2022
Study Start
November 7, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
The Steering Committee will decide if and how IPD will be shared. It is expected that study Co Investigators will be able to access data once the primary results have been presented.