Endothelial Function, Arterial Stiffness and Components
2 other identifiers
observational
32
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 21, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedApril 17, 2013
April 1, 2013
1.7 years
September 21, 2011
April 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
measure of endothelial
at enrollment
Eligibility Criteria
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.
You may qualify if:
- Survivor:
- 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
- Biological sibling
- Ages 8-28 (when more than one sibling is available the one closest in age will be chosen.))
You may not qualify if:
- Uncontrolled medical conditions that could interfere with participation or interpretation of results
- History of relapsed ALL or history of bone marrow transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2011
First Posted
September 23, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
April 17, 2013
Record last verified: 2013-04