Vascular Assessment in Adult Survivors of Childhood Cancer

Completed

Conditions studied: Cardiovascular Risk, Pediatric Cancer

In brief

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.

Key facts

Study ID

NCT02010190

Run by

St. Jude Children's Research Hospital

People needed

394

Starts

2013-12-01

Expected to finish

2016-07-01

Last updated by the study team

2016-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Cancer Survivors:
• Treatment with chemotherapy and/or radiation therapy for a primary cancer diagnosed prior to age 21 years at St. Jude Children's Research Hospital (SJCRH).
• ≥ 18 years of age at time of enrollment
• Enrollment on the SJCRH SJLIFE protocol
• No non-steroidal anti-inflammatory drug (NSAID) and/or aspirin (ASA) (≥ 325 mg) for 24 hours prior to testing.
• Control Group:
• No history of or current treatment for any medical condition with therapeutic chemotherapy or radiation exposures
• ≥18 years of age at time of enrollment
• Enrolled on the SJCRH SJLIFE protocol as a community control
• No NSAID and/or ASA (≥ 325 mg) for 24 hours prior to testing.

You may not qualify if…

• Active chronic inflammatory disease
• Diagnosis of sickle cell disease
• Current active infection
• On chronic anti-inflammatory medications
• History of upper extremity vascular bypass surgery or grafting.
• No active treatment with:
• β- and α-adrenergic receptor antagonists (treat high blood pressure)
• α-2 adrenergic agonists (treat high blood pressure)
• Calcium channel antagonists (treat high blood pressure or chest pain)
• HMG-CoA reductase inhibitors (treat high cholesterol)
• Angiotensin-converting enzyme (ACE) inhibitors (treat high blood pressure, heart failure, and heart disease)
• Angiotensin II receptor antagonists (treat high blood pressure and heart failure)
• Diuretics (treat high blood pressure and heart failure)
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Currently pregnant (assessed by serum pregnancy test)
• A first-degree relative of a survivor participant (controls only)

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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