Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume in Patients With Non-Small Cell Lung Cancer: A Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in aortic plaque volume
研究概览
简要总结
In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment leads to an accelerated progression of atherosclerosis in patients with lung cancer. Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being targeted for cancer are critical negative regulators of atherosclerosis in animal and cellular models. Aortic plaque progression will be compared between cases (on ICI) and controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will be matched for age, cancer type and stage and cardiovascular risk factors. Traditional markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination therapy, number of cycles, occurrence of immune-related adverse events, chest radiation, steroid use) will be associated with the change in aortic plaque volume.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with non-small cell lung cancer treated with Immune Checkpoint Inhibitors.
- •Available contrast enhanced CT scans of the chest both immediately pre-ICI (< 1 month) and latest follow-up.
- •Subjects with non-small cell lung cancer, age, cancer stage and cardiovascular risk factor matched to cases.
- •Available contrast enhanced CT scan of the chest at two time-points at a similar interval between scans as the cases.
排除标准
- 未提供
结局指标
主要结局
Change in aortic plaque volume
时间窗: Three years
The change of plaque burden after starting ICIs will be calculated and compared with the pre-ICI study. The change in plaque burden in controls will be calculated and compared from two studies at a similar median interval as ICI cases.
次要结局
未报告次要终点
研究者
Tomas G. Neilan, MD
Principal Investigator
Massachusetts General Hospital
