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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

September 21, 2011
April 15, 2013
June 2011
February 2013   (final data collection date for primary outcome measure)
measure of endothelial [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01439217 on ClinicalTrials.gov Archive Site
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Endothelial Function, Arterial Stiffness and Components
Endothelial Function, Arterial Stiffness and Components of Metabolic Syndrome in Acute Lymphoblastic Leukemia (ALL) Survivors

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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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.

Acute Lymphoblastic Leukemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
8 Years to 28 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01439217
J1064, NA_00040838
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
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Sidney Kimmel Comprehensive Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP