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Completed

NCT Number: NCT02010190

Vascular Assessment in Adult Survivors of Childhood Cancer

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.

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Key information

Conditions

Cardiovascular Risk Neoplasms Pediatric Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Mean high sensitivity C-reactive protein (hsCRP)

    Time frame: Once, at first clinic visit

  2. Mean fibrinogen

    Time frame: Once, at first clinic visit

  3. Mean CEC surface expression of vascular cell adhesion molecule-1 (VCAM-1)

    Time frame: Once, at first clinic visit

  4. Mean larger artery elasticity

    Time frame: Once, at first clinic visit

Secondary outcomes

  1. Mean number of circulating endothelial cells (CECs)

    Time frame: Once, at first clinic visit

  2. Mean CEC surface expression of P-selectin

    Time frame: Once, at first clinic visit

  3. Mean soluble vascular cell adhesion molecule-1 (VCAM-1)

    Time frame: Once, at first clinic visit

  4. Mean soluble P-selectin

    Time frame: Once, at first clinic visit

  5. Mean von Willebrand factor (vWF)

    Time frame: Once, at first clinic visit

  6. Mean D-dimer

    Time frame: Once, at first clinic visit

  7. Mean plasminogen activator inhibitor-1 (PAI-1)

    Time frame: Once, at first clinic visit

  8. Mean tissue-type plasminogen activator (tPA)

    Time frame: Once, at first clinic visit

  9. Mean lipoprotein(a)

    Time frame: Once, at first clinic visit

  10. Mean small artery elasticity (SAE)

    Time frame: Once, at first clinic visit

  11. Mean reactive hyperemia peripheral arterial tonometry (RH-PAT) ratio

    Time frame: Once, at first clinic visit

  12. Mean carotid-femoral pulse wave velocity

    Time frame: Once, at first clinic visit

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • University of Minnesota

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 12, 2013
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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