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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
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Scientific title
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
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Secondary ID [1]
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SOCRATES
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Universal Trial Number (UTN)
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Trial acronym
SOCRATES
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Atherosclerosis
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Condition category
Condition code
Cancer
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Malignant melanoma
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atorvastatin Calcium 40Mg Tab
Experimental: Statin treatment - Atorvastatin 40mg, daily, orally for 18 months
No intervention: No statin treatment - No comparator treatment/placebo allocated
Treatment: Drugs: Atorvastatin Calcium 40Mg Tab
One tablet daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in non-calcified plaque volume according to treatment with statins
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Assessment method [1]
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Difference in non-calcified plaque volume as measured on serial CTCA between patients treated with and without statin therapy
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Timepoint [1]
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18 months
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Secondary outcome [1]
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Change in total plaque volume in patients treated with ICI compared to historical cohorts
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Assessment method [1]
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Difference in total plaque volume as measured on serial CTCA between patients treated with ICI therapy against historical cohorts
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Timepoint [1]
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18 months
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Secondary outcome [2]
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Change in pericoronary adipose tissue attenuation and volume according to treatment with statins
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Assessment method [2]
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Difference in pericoronary adipose tissue attenuation and volume as measured on serial CTCA between patients treated with and without statin therapy
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Timepoint [2]
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18 months
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Secondary outcome [3]
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Cost-effectiveness of the use of CTCA as measured by net costs per life year gained in patients with melanoma treated with ICI therapy
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Assessment method [3]
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Differences in cost-effectiveness ratios in terms of net costs per life year gained between patients with melanoma treated with ICI therapy who had CTCA performed compared to historical cohorts who did not have CTCA performed
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Timepoint [3]
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18 months
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Secondary outcome [4]
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Incidence of adverse events with statin therapy
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Assessment method [4]
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Incidence and number of patients treated with and without statin therapy with reported adverse events and serious adverse events
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Timepoint [4]
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18 months
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Secondary outcome [5]
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Cost-effectiveness of statin therapy in patients with melanoma treated with ICI therapy as measured by net costs per life year gained
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Assessment method [5]
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Difference in cost-effectiveness ratios between patients with melanoma on ICI therapy who are treated with and without statin therapy, in terms of net costs per life year gained
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Timepoint [5]
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18 months
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Secondary outcome [6]
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Effect of statins on depression in patients with melanoma treated with ICI therapy as measured on the Patient Health Questionnaire-9
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Assessment method [6]
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Differences in mean changes in scores for the Patient Health Questionnaire-9 for each patient according to statin use, with a minimum score of 0 and a maximum score of 27, and higher scores indicating higher likelihood of depression
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Timepoint [6]
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18 months
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Secondary outcome [7]
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Effect of statins on anxiety in patients with melanoma treated with ICI therapy as measured on the Generalized Anxiety Disorder-7 questionnaire
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Assessment method [7]
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Differences in mean changes in scores for the Generalized Anxiety Disorder-7 questionnaire for each patient according to statin use, with a minimum score of 0 and a maximum score of 21, and higher scores indicating higher likelihood of anxiety
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Timepoint [7]
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18 months
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Secondary outcome [8]
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Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire
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Assessment method [8]
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Differences in mean changes in scores for the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire for each patient according to statin use, with a minimum score of 30 and a maximum score of 126, and higher scores indicating poorer quality of life
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Timepoint [8]
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18 months
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Secondary outcome [9]
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Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the EuroQoL Group EQ-5D questionnaire
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Assessment method [9]
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Differences in mean changes in scores for the EuroQoL Group EQ-5D questionnaire for each patient according to statin use, with a minimum score of 1 and a maximum score of 15, and higher scores indicating poorer quality of life
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Timepoint [9]
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18 months
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Secondary outcome [10]
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Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the FACT-M questionnaire
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Assessment method [10]
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Differences in mean changes in scores for each section of the FACT-M questionnaire for each patient according to statin use.
The score ranges for each individual section are: physical well-being 0-28, social well-being 0-28, emotional well-being 0-24, functional well-being 0-28, additional well-being 0-64, and melanoma-specific questions 0-32.
Interpretation of scoring depends on the individual sections in the questionnaire, with higher scores in the physical, emotional, additional and melanoma-specific questions indicating poorer quality of life, whilst lower scores in the social and emotional questions indicate poorer quality of life
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Timepoint [10]
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18 months
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Eligibility
Key inclusion criteria
* patients aged > or equal to 40 years
* historical or current diagnosis of stage 2, 3 or 4 melanoma treated with an ICI
* not currently treated with a statin ,and
* having acceptable imaging quality deemed by the core laboratory
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* inability to provide informed consent
* unwilling to be followed for serial evaluation
* contra-indication or intolerance to statins
* clinically manifest CV disease
* prognostic factors associated with an expected survival less than 18 months
* severe liver disease or advanced renal disease (³stage 3b CKD or eGFR <45 ml/min)
* any other factor that will preclude patients from participating in all study related activities
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Health - Clayton
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Recruitment hospital [2]
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Cabrini Health - Malvern
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Recruitment hospital [3]
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Latrobe Regional Hospital - Traralgon
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3144 - Malvern
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Recruitment postcode(s) [3]
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3844 - Traralgon
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will incorporate a prospective randomised open blinded end-point trial in participants with stage 2, 3 or 4 melanoma treated with ICI to evaluate the impact of statin therapy on changes in coronary plaque burden and composition.
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Trial website
https://clinicaltrials.gov/study/NCT05180942
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen J Nicholls, MBBS, PhD
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Julie Butters
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Address
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Country
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Phone
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+61434679018
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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.
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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