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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-PED-0872 | |||
| IRB# 081043 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a two-part study. Patients are enrolled in either part 1 or part 2.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | |||
| metabolic assessment | Other | |||
| questionnaire administration | Other | |||
| assessment of therapy complications | Procedure | |||
| fatigue assessment and management | Procedure | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Diet as assessed by the Food Frequency Questionnaire at baseline and at 6 and 12 months | ||
| Family history as assessed by the Family History Questionnaire at baseline | ||
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DISEASE CHARACTERISTICS:
Part 1
Diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL)
No T-cell ALL, very high-risk ALL, or infant ALL (< 1 year old at diagnosis)
Part 2
Diagnosis of precursor B-cell or T-cell ALL
Must have been diagnosed and treated (at least to the maintenance phase) at the Division of Pediatric Oncology at the Vanderbilt-Ingram Cancer Center within the past 7 years
No very high-risk ALL or infant ALL (< 1 year old at diagnosis)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Adam J. Esbenshade, 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 at Franklin |
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| Health-related quality of life as assessed by the Pediatric Quality of Life Inventory and the Pediatric Quality of Life Cancer Module at baseline and at 6 and 12 months |
| Physical activity as assessed by the Godlin Leisure Time Activity Questionnaire at baseline and at 6 and 12 months |
| Fatigue as assessed by the Pediatric Quality of Life Multidimensional Fatigue Survey at baseline and at 6 and 12 months |
| IGF-1, leptin, and adiponectin levels as assessed at baseline and at 12 months |
| Nashville |
| Tennessee |
| 37064 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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