Vascular Assessment in Adult Survivors of Childhood Cancer
- Conditions
- Cardiovascular RiskPediatric Cancer
- Registration Number
- NCT02010190
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief Summary
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.
- Detailed Description
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:
* Vital sign measurement including resting heart rate, blood pressure, height, and weight.
* Biomarker analysis will be completed by the Cytokine Reference Laboratory, Department of Pediatrics, University of Minnesota Medical School and the Vascular Biology Center (VBC), Department of Medicine, University of Minnesota Medical School.
* An echocardiogram to assess cardiac function.
* Pulse wave analysis will be measured with the CR-2000 Cardiovascular Profiling System.
* Pulse contour analysis will be studied using the Endo-PAT2000 system.
* Pulse wave velocity will be assessed using the SphygomoCor CVP Clinical System.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 394
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean fibrinogen Once, at first clinic visit Mean high sensitivity C-reactive protein (hsCRP) Once, at first clinic visit Mean CEC surface expression of vascular cell adhesion molecule-1 (VCAM-1) Once, at first clinic visit Mean larger artery elasticity Once, at first clinic visit
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States