Clinical trial · Observational
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
NCT05180942CI-TRIAL-00094190SOCRATESrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atherosclerosis | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.
- timeFrame
- 18 months
- description
- The change in non-calcified coronary plaque volume will be measured on serial computed tomography coronary angiography scans.
Secondary outcomes (7)
- measure
- To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.
- timeFrame
- 18 months
- measure
- To determine the relationship between statin use and the burden, composition and progression of coronary atherosclerosis in individuals with melanoma treated with ICIs.
- timeFrame
- 18 months
- description
- The change in non-calcified coronary plaque volume as measured on serial computed tomography coronary angiography scans will be compared between patients treated with statins and patients not treated with statins in the study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.