NCT02010190

Vascular Assessment in Adult Survivors of Childhood Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 394 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Risk
• Pediatric Cancer

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-12-12
• Last updated: 2016-07-27

Locations

1 site across 1 country: United States