Endothelial Function, Arterial Stiffness and Components

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sidney Kimmel Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT01439217

First received: September 21, 2011

Last updated: April 15, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 21, 2011
Last Updated Date	April 15, 2013
Start Date ^ICMJE	June 2011
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 15, 2013)	measure of endothelial [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01439217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Endothelial Function, Arterial Stiffness and Components
Official Title ^ICMJE	Endothelial Function, Arterial Stiffness and Components of Metabolic Syndrome in Acute Lymphoblastic Leukemia (ALL) Survivors
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	This descriptive, healthy sibling control study will utilize a convenience sample of 20 childhood ALL survivors, recruited from the Survivorship Program at Johns Hopkins (SPJH). The study will be introduced to survivors/parent/guardians during routine clinic visits. If they are interested in participation the consent form for both the survivor and sibling will be reviewed and taken home to discuss with the sibling and other family members. Follow-up phone call and questions will be encouraged. If all parties agree to participate an appointment will be set up to enroll the survivor/sibling and face to face informed consent will be obtained. A second method for recruitment will include mailings (see attached) to ALL survivors seen/treated at Johns Hopkins. Letters will include phone and email contacts to acquire further information and a post card to decline further contact.
Condition ^ICMJE	Acute Lymphoblastic Leukemia
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	32
Completion Date	February 2013
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Survivor: Inclusion 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) Off therapy for at least 6 months and not more than 10 years (6 months Inclusion Biological sibling Ages 8-28 (when more than one sibling is available the one closest in age will be chosen.)) Exclusion Criteria: Uncontrolled medical conditions that could interfere with participation or interpretation of results History of relapsed ALL or history of bone marrow transplantation
Gender	Both
Ages	8 Years to 28 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United States
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01439217
Other Study ID Numbers ^ICMJE	J1064, NA_00040838
Has Data Monitoring Committee	No
Responsible Party	Sidney Kimmel Comprehensive Cancer Center
Study Sponsor ^ICMJE	Sidney Kimmel Comprehensive Cancer Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sidney Kimmel Comprehensive Cancer Center
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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