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

NCT02032121 | Completed

• 1 other identifier: 20070584
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivor; Pediatric Cancer

Keywords

Cancer survivors; Long-term cancer survivor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention procedures

EXPERIMENTAL

All the procedures will be completed for every subject

Procedure: Blood specimen; Procedure: Echocardiography

Interventions

Blood specimen PROCEDURE

Intervention procedures

Echocardiography PROCEDURE

Also known as: Flow mediated vasodilation, Carotid intimal media thickness, Bone Mineral Density

Intervention procedures

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• years from the completion of therapy for cancer
• free of active disease

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami, MIller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection; Carotid Intima-Media Thickness; Bone Density

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Ultrasonography, Carotid Arteries; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tracie L Miller, MD, SM

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: October 1, 2007
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

US (1)