NCT05180942 Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
| NCT ID | NCT05180942 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Monash University |
| Condition | Melanoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2022-11-07 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2022-11-07 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Stephen J Nicholls, MBBS, PhD
PRINCIPAL INVESTIGATOR
Monash University
Frequently Asked Questions
Who can join the NCT05180942 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05180942 currently recruiting?
Yes, NCT05180942 is actively recruiting participants. Contact the research team at domenic.sacca@monash.edu for enrollment information.
Where is the NCT05180942 trial being conducted?
This trial is being conducted at Kingswood, Australia, Waratah, Australia, Bundaberg, Australia, Hervey Bay, Australia and 8 additional locations.
Who is sponsoring the NCT05180942 clinical trial?
NCT05180942 is sponsored by Monash University. The principal investigator is Stephen J Nicholls, MBBS, PhD at Monash University. The trial plans to enroll 130 participants.
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