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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA077598 | U.S. NIH Grant/Contract | View source | |
| UMN-2003NT063 | |||
| CDR0000642276 | Registry Identifier | NCI | |
| IR-6980 | Other Identifier | Former FHCRC IRB ID | |
| FHCRC-2357.00 | Other Identifier | Former FHCRC ID |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood leukemia who have undergone stem cell transplant may help doctors learn more about the disease and the long-term effects of leukemia treatment. It may also help improve the quality of life for future cancer survivors.
PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone stem cell transplant.
OBJECTIVES:
OUTLINE: Patients are stratified according to post-transplant follow-up period (2-9 years vs 10-15 years vs > 15 years).
Patients and their siblings undergo physical examination, a review of medical and family history, and blood pressure and anthropometric measurements. Patients and their siblings also undergo blood sample collection for laboratory studies (including analysis of C-reactive protein and CBC; lipid profile and triglycerides; leptin and adipokines; free thyroxine, TSH, IGF1, IGF3, and LH; and estradiol [females] or testosterone [males]); urine sample collection for microalbumin determination; and other study procedures (including euglycemic insulin clamp study; body composition and bone density [DEXA] study; bone-age x-ray [for patients < 18 years of age]; and vascular studies). Patients also undergo growth hormone stimulation testing.
Patients and their siblings complete questionnaires about their physical activity, dietary habits, and health knowledge.
PROJECTED ACCRUAL: A total of 193 childhood leukemia survivors and 193 healthy siblings will be accrued for this study.
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) with age- and gender-matched controls | ≥2 years post-HSCT | |
| Comparison of insulin resistance in patients with age- and gender-matched controls | ≥2 years post-HSCT | |
| Correlation between insulin sensitivity and risk factors associated with metabolic syndrome | ≥2 years post-HSCT | |
| Influence of time since transplant on insulin resistance | ≥2 years post-HSCT | |
| Peak growth hormone secretion in patients with insulin resistance and in those without | ≥2 years post-HSCT | |
| Growth hormone deficiency in patients with metabolic syndrome and in those without | ≥2 years post-HSCT | |
| Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity | ≥2 years post-HSCT | |
| Correlation of adiponectin with insulin resistance and central obesity | ≥2 years post-HSCT | |
| Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease | ≥2 years post-HSCT |
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DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Survivor of childhood leukemia, meeting all of the following criteria:
Healthy sibling of a childhood leukemia survivor
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Childhood leukemia survivors and healthy siblings, 9-21 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| K S Baker, MD, MS | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center - Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
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| Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without | ≥2 years post-HSCT |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D024821 | Metabolic Syndrome |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007951 | Leukemia, Myeloid |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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