Back to resultsVascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
Primary Purpose
Cancer Survivor, Pediatric Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood specimen
Echocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer Survivor focused on measuring Cancer survivors, Long-term cancer survivor
Eligibility 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
Sites / Locations
- University of Miami, MIller School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention procedures
Arm Description
All the procedures will be completed for every subject
Outcomes
Primary Outcome Measures
Vascular Inflammation
All study procedures to assess vascular inflammation will be assessed through specimen sample collection and through procedures such as (echocardiograph)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02032121
Brief Title
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
Official Title
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Pediatric Cancer
Keywords
Cancer survivors, Long-term cancer survivor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention procedures
Arm Type
Experimental
Arm Description
All the procedures will be completed for every subject
Intervention Type
Procedure
Intervention Name(s)
Blood specimen
Intervention Type
Procedure
Intervention Name(s)
Echocardiography
Other Intervention Name(s)
Flow mediated vasodilation, Carotid intimal media thickness, Bone Mineral Density
Primary Outcome Measure Information:
Title
Vascular Inflammation
Description
All study procedures to assess vascular inflammation will be assessed through specimen sample collection and through procedures such as (echocardiograph)
Time Frame
single time point at initial visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracie L Miller, MD, SM
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami, MIller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
We'll reach out to this number within 24 hrs