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Endothelial Function, Arterial Stiffness and Components

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ClinicalTrials.gov Identifier: NCT01439217
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : April 17, 2013
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center

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.

Condition or disease
Acute Lymphoblastic Leukemia

Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Endothelial Function, Arterial Stiffness and Components of Metabolic Syndrome in Acute Lymphoblastic Leukemia (ALL) Survivors
Study Start Date : June 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Primary Outcome Measures :
  1. measure of endothelial [ Time Frame: at enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Inclusion Criteria:



  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


  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439217

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01439217     History of Changes
Other Study ID Numbers: J1064
NA_00040838 ( Other Identifier: JHMIRB )
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Acute lymphoblastic leukemia
Sibling control

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases