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OpenTrials
Completed

NCT Number: NCT02032121

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

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.

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Key information

Age range

6 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, MIller School of Medicine

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Blood specimen

Procedure

Echocardiography

Procedure

Other names: Flow mediated vasodilation, Carotid intimal media thickness, Bone Mineral Density

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2014
Registry last updated
Sep 9, 2015

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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