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| ID | Type | Description | Link |
|---|---|---|---|
| 0411M65666 | Other Identifier | IRB, University of Minnesota |
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RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease.
PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo a comprehensive medical examination including current and past medical history, family history, review of prescription medications, a physical examination including a body and visceral-fat assessment, and anthropometric (DEXA and bone-age x-ray) and blood pressure measurement. Blood samples are collected to measure growth hormone, adipokines (adiponectin, leptin), cytokines (IL-6 and CRP), fasting insulin, fasting glucose, lipids, oxidized LDL, hypothalami-pituitary-gonadal function (estrogen, FSH, LH, testosterone), and thyroid function (free T4 and TSH). Patients also complete questionnaires on dietary intake and physical activity.
Healthy siblings undergo a complete medical examination as patients do, including blood samples collection and questionnaire administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer Survivors | Subjects who are cancer survivors must have survived childhood cancer (diagnosed < or = 18 years) for a minimum of 5 years and be in remission. |
| |
| Healthy Siblings of Cancer Survivor | Healthy populations similar in age and gender distribution, derived from a frequency matched control population of 350 healthy siblings. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metabolic assessment | Other | Physical examination, medical history, blood pressure, anthropometrics, laboratory studies and other procedures (body composition, bone density, growth hormone, vascular, functional mobility, body fat assessments, etc). |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls | Day 1 and Day 2 | |
| Insulin resistance (IR) in CCS vs controls | Day 1 and Day 2 | |
| Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS | Day 1 and Day 2 | |
| Dietary and a physical activity assessments of CCS vs controls | Day 1 and Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS | Day 1 and Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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The childhood cancer survivor (CCS) subjects for this study will be selected from Pediatric Oncology databases at the University of Minnesota Medical Center and Children"s Hospitals and Clinics of Minneapolis and St. Paul as described previously. CCS will complete a comprehensive evaluation in the Masonic Clinical Research Unit (MCRU) over a 2 day time period. The comparative data on normal children and adolescents will be obtained from healthy siblings frequency matched by age and gender and who will be evaluated in a manner similar to the CCS.
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| Name | Affiliation | Role |
|---|---|---|
| Julia Steinberger, MD, MS | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Children's Hospital - Fairview | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D024821 | Metabolic Syndrome |
| D012509 | Sarcoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D001254 | Astrocytoma |
| D016545 | Choroid Plexus Neoplasms |
| C531673 | Familial ependymoma |
| D009837 | Oligodendroglioma |
| D020339 | Optic Nerve Glioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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A 22 gauge intravenous polyethylene catheter will be inserted into an antecubital vein of one arm and the necessary blood for all baseline laboratory studies will be obtained and processed as per standard protocol.
| questionnaire administration | Other | Dietary habits will be evaluated using the Youth/ Adolescent Questionnaire (YAQ)and the Modifiable Activity Questionnaire for Adolescents (MAQA) will be used to assess participation in leisure time and competitive activities during the past year will be administered on Day 2. |
|
|
| D009370 |
| Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D007945 | Leukemia, Lymphoid |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |