Endothelial Function, Arterial Stiffness and Components

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Endothelial Function, Arterial Stiffness and Components of Metabolic Syndrome in Acute Lymphoblastic Leukemia (ALL) Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439217
• Other study ID #: J1064
• Secondary ID: NA_00040838
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: April 15, 2013
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 28 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of endothelial		at enrollment	No