Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sizes of plaque areas at the same locations on artery ultrasound
研究概览
简要总结
Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
详细描述
This is a self-control, multi-center observational study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs on atherosclerotic plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the plaque areas at the same location of artery in each patient before and after anti-PD-1 mAbs treatments, to assess the progression of atherosclerotic plaques response to anti-PD-1 mAbs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age is 18-90 years old (including 18 and 90 years old);
- •The subjects knew about the experiment and signed the informed consent voluntarily;
- •The subjects complicated with tumor diseases and atherosclerotic plaques;
- •The subjects received regular PD-1 inhibitor treatment;
- •The subjects had ultrasound images of atherosclerotic plaques before- and after- or during PD-1 blockade treatment at the two different timepoints;
- •The subjects received regular treatments of PD-1 inhibitor during the two timepoints of artery ultrasound examinations;
- •The subjects who had ultrasound images before the initiation of first-dose PD-1 inhibitor, the interval between these two timepoints should be restricted within 1 month;
- •The subjects who had ultrasound images after 3 months of PD-1 inhibitor treatment.
排除标准
- •Subjects stop receiving PD-1 inhibitor treatments during follow-up;
- •Subjects are reluctant to continue to be involved in this study; Known pregnant and lactating women;
- •Plaque areas can not be calculated because of the quality of ultrasound image;
- •Other situations that the researchers judged were not suitable for inclusion.
结局指标
主要结局
Sizes of plaque areas at the same locations on artery ultrasound
时间窗: at least of 3 months after the first dosage of anti-PD-1 mAbs
Comparison of the sizes of plaque areas at the same locations on artery ultrasound before and after anti-PD-1 mAbs treatments.
次要结局
未报告次要终点