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Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02032121
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Tracie L. Miller, MD, University of Miami

Brief Summary:
Survivors of childhood cancer have an increased risk of death from cardiovascular disease due to both the therapies they received while undergoing treatment and diet and lifestyle factors. The nature of cardiovascular risk and the interaction between treatment affects and cardiovascular risk factors is unknown. We propose to study vascular inflammatory markers as well as measure of blood vessel stiffness (both of which are predictive of early heart disease) in 100 pediatric cancer survivors and 100 control children. Characterization of vascular inflammation and stiffness in long-term survivors will allow for the development of future interventions to decrease inflammation through both pharmacologic and lifestyle modifications.

Condition or disease Intervention/treatment Phase
Cancer Survivor Pediatric Cancer Procedure: Blood specimen Procedure: Echocardiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
Study Start Date : October 2007
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention procedures
All the procedures will be completed for every subject
Procedure: Blood specimen
Procedure: Echocardiography
Other Names:
  • Flow mediated vasodilation
  • Carotid intimal media thickness
  • Bone Mineral Density




Primary Outcome Measures :
  1. Vascular Inflammation [ Time Frame: single time point at initial visit ]
    All study procedures to assess vascular inflammation will be assessed through specimen sample collection and through procedures such as (echocardiograph)



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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 6-30 years of age
  • 2 years from the completion of therapy for cancer
  • free of active disease

Exclusion Criteria:

  • <6 or > 30 years of age
  • current cancer treatment or inside of 2 years post treatment
  • Active disease/infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032121


Locations
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United States, Florida
University of Miami, MIller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Tracie L Miller, MD, SM University of Miami

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Responsible Party: Tracie L. Miller, MD, Professor of Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT02032121     History of Changes
Other Study ID Numbers: 20070584
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Keywords provided by Tracie L. Miller, MD, University of Miami:
Cancer survivors
Long-term cancer survivor
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes