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

NCT ID: NCT02032121

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Cancer Survivor Pediatric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention procedures

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Group Type EXPERIMENTAL

Blood specimen

Intervention Type PROCEDURE

Echocardiography

Intervention Type PROCEDURE

Interventions

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Blood specimen

Intervention Type PROCEDURE

Echocardiography

Intervention Type PROCEDURE

Other Intervention Names

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Flow mediated vasodilation Carotid intimal media thickness Bone Mineral Density

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Tracie L. Miller, MD

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tracie L Miller, MD, SM

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami, MIller School of Medicine

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20070584

Identifier Type: -

Identifier Source: org_study_id

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