Vascular Assessment in Adult Survivors of Childhood Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Mean fibrinogen
研究概览
简要总结
This is an observational study that will collect data from adult survivors of childhood cancer and compare it to data collected from age- and gender-matched controls for the purpose of assessing vascular risk among cancer survivors.
Advances in cancer therapies have led to increasing numbers of adults previously treated for a pediatric malignancy, many of whom experience late adverse health-related sequelae and are at risk for developing chronic conditions related to their prior therapy. The epidemiology of many end-organ toxicities has been described, yet the pathophysiologic mechanisms of injury are incompletely understood. One mechanism may be damage to the circulatory system, in particular the endothelial layer, initiating an inflammatory state leading to dysfunction and premature atherosclerotic disease. This process may begin and significantly progress in a sub-clinical nature for many years prior to manifesting as a cardio- or cerebrovascular event. Using established and novel biomarkers predictive of atherosclerotic disease combined with unique measurements of vascular function, this study will assess pre-clinical vascular disease in a population of childhood and adolescent cancer survivors. The goals of this project are to investigate the effects of cancer therapy on the vascular system and acquire new knowledge with which to risk-stratify survivors and plan interventional studies to prevent or reduce premature vascular morbidity and mortality.
详细描述
PRIMARY OBJECTIVES:
- Evaluate biomarkers of vascular injury (inflammation, hemostasis, endothelial activation) among childhood cancer survivors compared to age/gender-matched controls.
- Assess vascular function among childhood cancer survivors compared to age/gender-matched controls.
SECONDARY OBJECTIVE:
- Investigate additional biomarkers of vascular health and function among childhood cancer survivors compared to age/gender-matched controls.
Eligible persons who consent to participate in this trial will be asked to do the following:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean fibrinogen
时间窗: Once, at first clinic visit
Mean high sensitivity C-reactive protein (hsCRP)
时间窗: Once, at first clinic visit
Mean CEC surface expression of vascular cell adhesion molecule-1 (VCAM-1)
时间窗: Once, at first clinic visit
Mean larger artery elasticity
时间窗: Once, at first clinic visit
次要结局
- Mean von Willebrand factor (vWF)(Once, at first clinic visit)
- Mean tissue-type plasminogen activator (tPA)(Once, at first clinic visit)
- Mean reactive hyperemia peripheral arterial tonometry (RH-PAT) ratio(Once, at first clinic visit)
- Mean D-dimer(Once, at first clinic visit)
- Mean plasminogen activator inhibitor-1 (PAI-1)(Once, at first clinic visit)
- Mean small artery elasticity (SAE)(Once, at first clinic visit)
- Mean number of circulating endothelial cells (CECs)(Once, at first clinic visit)
- Mean carotid-femoral pulse wave velocity(Once, at first clinic visit)
- Mean CEC surface expression of P-selectin(Once, at first clinic visit)
- Mean soluble vascular cell adhesion molecule-1 (VCAM-1)(Once, at first clinic visit)
- Mean lipoprotein(a)(Once, at first clinic visit)
- Mean soluble P-selectin(Once, at first clinic visit)