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
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Tracking Information | |||
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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 |
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 |
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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. |
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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. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
32 | ||
Original Estimated Enrollment |
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
Inclusion
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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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 |