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

Not Applicable

Completed

• Conditions: Pediatric Cancer; Cancer Survivor
• Interventions: Procedure: Blood specimen; Procedure: Echocardiography

• Registration Number: NCT02032121
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention procedures	Blood specimen	All the procedures will be completed for every subject
Intervention procedures	Echocardiography	All the procedures will be completed for every subject

Primary Outcome Measures

Name	Time	Method
Vascular Inflammation	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)

Trial Locations

Locations (1)

University of Miami, MIller School of Medicine; 🇺🇸 Miami, Florida, United States