Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission
This study is currently recruiting participants.
Verified November 2008 by National Cancer Institute (NCI)
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00801346
First received: December 2, 2008
Last updated: August 11, 2009
Last verified: November 2008
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 2, 2008 | ||||||||
| Last Updated Date | August 11, 2009 | ||||||||
| Start Date ICMJE | November 2008 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Development of components of metabolic syndrome as assessed by clinical measures (e.g., body mass index, waist circumference, and blood pressure) and laboratory measures (e.g., fasting lipid profile and fasting insulin and glucose) [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00801346 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission | ||||||||
| Official Title ICMJE | The Metabolic Syndrome in Pediatric Acute Lymphoblastic Leukemia (ALL). | ||||||||
| Brief Summary | RATIONALE: Gathering information about metabolic syndrome from young patients with acute lymphoblastic leukemia may help doctors learn more about the disease. PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute lymphoblastic leukemia in remission. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a two-part study. Patients are enrolled in either part 1 or part 2.
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Not Provided | ||||||||
| Study Population | Not Provided | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* 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 ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 45 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Part 1
Part 2
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||||||
| Ages | 1 Year to 20 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Not Provided | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00801346 | ||||||||
| Other Study ID Numbers ICMJE | CDR0000624471, VU-VICC-PED-0872, IRB# 081043 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Adam J. Esbenshade, Vanderbilt-Ingram Cancer Center | ||||||||
| Study Sponsor ICMJE | Vanderbilt-Ingram Cancer Center | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | November 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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