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Cardiovascular RiskNCT02010190

Vascular Assessment in Adult Survivors of Childhood Cancer

An observational study of Cardiovascular Risk and Pediatric Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiovascular Risk, Pediatric Cancer
How many people
394 participants
Where
1 siteUnited States
Study dates
Dec 2013to Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 202 potential cancer survivor participants will be recruited from the St. Jude Children's Research Hospital (SJCRH) SJLIFE Cohort Study and stratified by survival time (10-14, 15-19, 20-24, 25-29, and ≥ 30 years). 202 potentially eligible comparison group participants will be recruited from the parent, sibling, relative or friend population who accompany patients to SJCRH. Control participants will not be a first-degree relative of a survivor participant. Potential comparison group members will be matched to potentially eligible participants by gender and age group.

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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:
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

Other trials in United States

About this study

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.

Read the 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.
Keywords
Pediatric malignancies, Cancer survivors, Coronary artery risk, Vascular function, Cardiovascular risk in survivors of pediatric cancer
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02010190
Study groupRoleWhat they receive
Cancer SurvivorsParticipants will be survivors of a childhood cancer.
Control GroupControl participants will consist of age- and gender-matched individuals who are non-first-degree relatives of the survivor group.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Once, at first clinic visit

  2. Mean fibrinogen

    Measured: Once, at first clinic visit

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

    Measured: Once, at first clinic visit

  4. Mean larger artery elasticity

    Measured: Once, at first clinic visit

Secondary outcomes (12)

  1. Mean number of circulating endothelial cells (CECs)

    Measured: Once, at first clinic visit

  2. Mean CEC surface expression of P-selectin

    Measured: Once, at first clinic visit

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

    Measured: Once, at first clinic visit

  4. Mean soluble P-selectin

    Measured: Once, at first clinic visit

  5. Mean von Willebrand factor (vWF)

    Measured: Once, at first clinic visit

  6. Mean D-dimer

    Measured: Once, at first clinic visit

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

    Measured: Once, at first clinic visit

  8. Mean tissue-type plasminogen activator (tPA)

    Measured: Once, at first clinic visit

  9. Mean lipoprotein(a)

    Measured: Once, at first clinic visit

  10. Mean small artery elasticity (SAE)

    Measured: Once, at first clinic visit

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

    Measured: Once, at first clinic visit

  12. Mean carotid-femoral pulse wave velocity

    Measured: Once, at first clinic visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02010190
Sponsor's protocol ID
VASCC
Status last verified
Jul 2016
First submitted
9 Dec 2013
Last updated
27 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Risk and Pediatric Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean high sensitivity C-reactive protein (hsCRP) (time frame: Once, at first clinic visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02010190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.

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