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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenic Sacca | Contact | +61 (0) 423245187 | domenic.sacca@monash.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen J Nicholls, MBBS, PhD | Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nepean Hospital | Recruiting | Kingswood | New South Wales | 2747 | Australia |
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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Optional blood samples will be collected for Future Biomedical Research
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.
| 18 months |
| To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs. | The number of patients who were started on statin therapy by their treating clinicians after undergoing computed tomography coronary angiography in the study will be recorded. | 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. | Quality of life will be assessed by using the PHQ-9, GAD-7, EORTC QLQ-C30, EuroQOL EQ-5D, and FACT-M questionnaires at baseline and at 18 month follow up. The change in quality of life scores on each questionnaire will be compared with historical cohorts that have previously been reported in the literature. | 18 months |
| To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs. | 18 months |
| To determine progression free survival with regard to the underlying melanoma following treatment with ICIs. | 18 months |
| To determine overall survival in patients with melanoma treated with ICIs. | 18 months |
| Calvary Mater Newcastle | Recruiting | Waratah | New South Wales | 2298 | Australia |
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| Bundaberg Base Hospital | Recruiting | Bundaberg | Queensland | 4670 | Australia |
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| Hervey Bay Hospital | Recruiting | Hervey Bay | Queensland | 4655 | Australia |
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| Ipswich Hospital | Recruiting | Ipswich | Queensland | 4305 | Australia |
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| Toowoomba Hospital | Recruiting | Toowoomba | Queensland | 4350 | Australia |
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| Queen Elizabeth Hospital | Recruiting | Woodville South | South Australia | 5011 | Australia |
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| Monash Health | Recruiting | Clayton | Victoria | 3168 | Australia |
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| Peninsula Health | Recruiting | Frankston | Victoria | 3199 | Australia |
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| Cabrini Health | Recruiting | Malvern | Victoria | 3144 | Australia |
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| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3051 | Australia |
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| Mildura Public Base Hospital | Recruiting | Mildura | Victoria | 3500 | Australia |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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