Vascular Assessment in Adult Survivors of Childhood Cancer

Pediatric Cancer Clinical Trial

Official title:

Vascular Assessment in Adult Survivors of Childhood Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010190
• Other study ID #: VASCC
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: July 26, 2016
• Start date: December 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• ß- and a-adrenergic receptor antagonists (treat high blood pressure)

• a-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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Risk
• Pediatric Cancer

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	University of Minnesota, MN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean high sensitivity C-reactive protein (hsCRP)		Once, at first clinic visit	No
Primary	Mean fibrinogen		Once, at first clinic visit	No
Primary	Mean CEC surface expression of vascular cell adhesion molecule-1 (VCAM-1)		Once, at first clinic visit	No
Primary	Mean larger artery elasticity		Once, at first clinic visit	No
Secondary	Mean number of circulating endothelial cells (CECs)		Once, at first clinic visit	No
Secondary	Mean CEC surface expression of P-selectin		Once, at first clinic visit	No
Secondary	Mean soluble vascular cell adhesion molecule-1 (VCAM-1)		Once, at first clinic visit	No
Secondary	Mean soluble P-selectin		Once, at first clinic visit	No
Secondary	Mean von Willebrand factor (vWF)		Once, at first clinic visit	No
Secondary	Mean D-dimer		Once, at first clinic visit	No
Secondary	Mean plasminogen activator inhibitor-1 (PAI-1)		Once, at first clinic visit	No
Secondary	Mean tissue-type plasminogen activator (tPA)		Once, at first clinic visit	No
Secondary	Mean lipoprotein(a)		Once, at first clinic visit	No
Secondary	Mean small artery elasticity (SAE)		Once, at first clinic visit	No
Secondary	Mean reactive hyperemia peripheral arterial tonometry (RH-PAT) ratio		Once, at first clinic visit	No
Secondary	Mean carotid-femoral pulse wave velocity		Once, at first clinic visit	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital