Endothelial Function, Arterial Stiffness and Components

NCT ID: NCT01439217

Last Updated: 2013-04-17

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

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00040838

Identifier Type: OTHER

Identifier Source: secondary_id

J1064

Identifier Type: -

Identifier Source: org_study_id

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