NCT05180942招募中2 期
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 12
- 主要终点
- To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.
时间窗: 18 months
The change in non-calcified coronary plaque volume will be measured on serial computed tomography coronary angiography scans.
次要结局
- 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.(18 months)
- To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs.(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.(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)
研究者
Stephen Nicholls
Professor
Monash University
研究点 (12)
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