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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032121
• Other study ID #: 20070584
• Status: Completed
• Phase: N/A
• First received: January 8, 2014
• Last updated: September 8, 2015
• Start date: October 2007
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 30 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer Survivor
• Pediatric Cancer

Intervention

Procedure:
• Blood specimen

• Echocardiography

Locations

Country	Name	City	State
United States	University of Miami, MIller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular Inflammation	All study procedures to assess vascular inflammation will be assessed through specimen sample collection and through procedures such as (echocardiograph)	single time point at initial visit	No