Endothelial Function, Arterial Stiffness and Components

Completed

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT01439217
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

Specific Aim: Compare the endothelial function, arterial stiffness and components of metabolic syndrome of childhood Acute Lymphoblastic Leukemia (ALL) survivors to healthy sibling controls. Plan: A cross sectional study comparing ALL survivors to sibling controls including measures of endothelial function and arterial stiffness obtained form a peripheral artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and insulin.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Survivor:

Inclusion

1. Ages 8-28 (8 is chosen as lower age limit because developmental understanding will allow survivor to follow instructions for procedures, 28 is chosen as upper limit to include age ranges seen for treatment in the pediatric program)
2. Off therapy for at least 6 months and not more than 10 years (6 months

Inclusion

1. Biological sibling
2. Ages 8-28 (when more than one sibling is available the one closest in age will be chosen.))

Exclusion Criteria

1. Uncontrolled medical conditions that could interfere with participation or interpretation of results
2. History of relapsed ALL or history of bone marrow transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measure of endothelial	at enrollment

Trial Locations

Locations (2)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States