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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05180942




Registration number
NCT05180942
Ethics application status
Date submitted
11/11/2021
Date registered
6/01/2022

Titles & IDs
Public title
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Scientific title
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Secondary ID [1] 0 0
SOCRATES
Universal Trial Number (UTN)
Trial acronym
SOCRATES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Atherosclerosis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
To determine the relationship between statin use and the burden, composition and progression of coronary atherosclerosis in individuals with melanoma treated with ICIs.
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs.
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
To evaluate the impact of participation in a cardio-oncology trial on measures of quality of life in patients with melanoma treated with ICIs.
Timepoint [4] 0 0
18 months
Secondary outcome [5] 0 0
To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs.
Timepoint [5] 0 0
18 months
Secondary outcome [6] 0 0
To determine progression free survival with regard to the underlying melanoma following treatment with ICIs.
Timepoint [6] 0 0
18 months
Secondary outcome [7] 0 0
To determine overall survival in patients with melanoma treated with ICIs.
Timepoint [7] 0 0
18 months

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [3] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment hospital [5] 0 0
Peninsula Health - Frankston
Recruitment hospital [6] 0 0
Cabrini Health - Malvern
Recruitment hospital [7] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [8] 0 0
Mildura Public Base Hospital - Mildura
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4305 - Ipswich
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
3051 - Melbourne
Recruitment postcode(s) [8] 0 0
3500 - Mildura

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen J Nicholls, MBBS, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Domenic Sacca
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 423245187
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05180942