Endothelial Function, Arterial Stiffness and Components
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Purpose
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 |
|---|
|
Acute Lymphoblastic Leukemia |
| Study Type: | Observational |
| Study Design: | 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 |
Eligibility| Ages Eligible for Study: | 8 Years to 28 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| Sidney Kimmel Comprehensive Cancer Center | |
| Baltimore, Maryland, United States, 21287 | |
More Information
No publications provided
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01439217 History of Changes |
| Other Study ID Numbers: | J1064, NA_00040838 |
| Study First Received: | September 21, 2011 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
Acute lymphoblastic leukemia Survivor Sibling control |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013