Vascular Assessment in Adult Survivors of Childhood Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/28/2016 |
| Start Date: | December 2013 |
| End Date: | July 2016 |
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.
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.
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.
- 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.
INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
- 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)
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Daniel A. Mulrooney, MD
Phone: 866-278-5833
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