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| ID | Type | Description | Link |
|---|---|---|---|
| VU-VICC-PED-0888 | |||
| 081208 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Gathering information about metabolic syndrome from young patients who have survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease.
PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have survived acute lymphoblastic leukemia and in healthy sibling volunteers.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients' medical charts are reviewed and patients undergo anthropometric measuring (height and weight for BMI calculation and waist and hip circumferences) and blood pressure testing. Patients also complete questionnaires on their physical activity, diet, and family history over 30-45 minutes. Blood is collected to measure cytokines (e.g., adiponectin, leptin, interleukin-6, and C-reactive protein), fasting glucose, and fasting insulin.
Healthy volunteers undergo anthropometric measuring and blood pressure testing (if they are seen in the clinic). They also complete a baseline medical history and questionnaires on their physical activity and diet.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other |
| ||
| medical chart review | Other |
| ||
| metabolic assessment | Other |
| ||
| questionnaire administration | Other | will be obtained at a single clinic visit |
| |
| assessment of therapy complications | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers | 2009-2011 | |
| Host- and treatment-related risk factors for MS | 2009-2011 |
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Inclusion Criteria:
DISEASE CHARACTERISTICS:
Meets one of the following eligibility criteria:
Childhood acute lymphoblastic leukemia survivor
Less than 22 years old at diagnosis
Treated from 1990-2007 at one of the following locations:
Meets 1 of the following treatment criteria:
No evidence of recurrent disease
Healthy volunteer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Exclusion Criteria:
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A minimum target accrual at each institution is 25 subjects for each treatment modality and 25 siblings, for a total of 75 study participants at VCH. An attempt will be made to approach equal numbers of male and female survivors.
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| Name | Affiliation | Role |
|---|---|---|
| Jill Simmons, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States | ||
| Vanderbilt-Ingram Cancer Center |
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Banked DNA
| Nashville |
| Tennessee |
| 37232-6838 |
| United States |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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