Endothelial Function, Arterial Stiffness and Components

Tracking Information
First Submitted Date	September 21, 2011
First Posted Date	September 23, 2011
Last Update Posted Date	April 17, 2013
Study Start Date	June 2011
Actual Primary Completion Date	February 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: April 15, 2013)	measure of endothelial [ Time Frame: at enrollment ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01439217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Endothelial Function, Arterial Stiffness and Components
Official Title	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	Observational
Study Design	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	Acute Lymphoblastic Leukemia
Intervention	Not Provided
Study Groups/Cohorts	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	Completed
Actual Enrollment; (submitted: April 15, 2013)	32
Original Estimated Enrollment; (submitted: September 22, 2011)	40
Actual Study Completion Date	February 2013
Actual Primary Completion Date	February 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	8 Years to 28 Years (Child, Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01439217
Other Study ID Numbers	J1064; NA_00040838 ( Other Identifier: JHMIRB )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Sidney Kimmel Comprehensive Cancer Center
Study Sponsor	Sidney Kimmel Comprehensive Cancer Center
Collaborators	Not Provided
Investigators	Not Provided
PRS Account	Sidney Kimmel Comprehensive Cancer Center
Verification Date	April 2013