A Perspective, Self-control Study on the Progression of Carotid 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
- The mean intima-media thickness of the common carotid artery
研究概览
简要总结
A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
详细描述
This is a perspective, self-controlled cohort study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs (PD-1 immune checkpoint blockades) on atherosclerotic carotid plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the: ① The mean intima-media thickness of the common carotid artery (Mean CCA thickness); ② The maximum intima-media thickness of the internal carotid artery (maximum ICA thickness); ③ Carotid plaque burden: by calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the above-mentioned parameters at the same location of carotid artery in each patient when initiate the first-dose of anti-PD-1 mAbs therapy and 3 months post anti-PD-1 mAbs therapy. It is designed to assess the effectiveness of anti-PD-1 mAbs on the progression of carotid plaques.
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
- 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 of subjects are between 18-90 years old (including 18 and 90 years old);
- •All kinds of tumor diseases of subjects are acceptable;
- •All kinds of PD-1 immune checkpoint blockades or dosages are acceptable;
- •The subjects knew about the experiment and signed the informed consent voluntarily;
- •The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months;
- •The subjects complicated with atherosclerotic carotid plaques.
排除标准
- •Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up;
- •Subjects are reluctant to continue to be involved in this study;
- •Known pregnant and lactating women;
- •The parameters (e.g., CCA intima-media, ICA intima-media or carotid plaque burden) could 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
The mean intima-media thickness of the common carotid artery
时间窗: 3 months
It was measured over a segment of the common carotid artery that was 1 cm long, located approximately 0.5 cm below the carotid-artery bulb, and considered not to contain any plaque (i.e., not to have any perceivable protrusion of the artery wall into the lumen).
Carotid plaque burden
时间窗: 3 months
Carotid plaque area measured by ultrasound (cross-sectional area of longitudinal views of all plaques seen) to quantify the increase or decrease of atherosclerotic carotid plaques.
The maximum intima-media thickness of the internal carotid artery
时间窗: 3 months
It was defined as the greatest intima-media thickness in either the right or left internal carotid artery extending from the bulb to 1 cm above the carotid sinus, ascertained from a total of four views on each side.
次要结局
未报告次要终点