Metabolic Syndrome in Childhood Cancer Survivors
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors Leukemia Lymphoma Metabolic Syndrome Sarcoma |
Other: metabolic assessment Other: questionnaire administration |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Metabolic Syndrome in Childhood Cancer Survivors |
- Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]
- Insulin resistance (IR) in CCS vs controls [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]
- Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]
- Dietary and a physical activity assessments of CCS vs controls [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]
- Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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.
| Enrollment: | 512 |
| Study Start Date: | April 2005 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Other: metabolic assessment
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).
Other: questionnaire administration
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.
Other Names:
|
|
Healthy Siblings of Cancer Survivor
Healthy populations similar in age and gender distribution, derived from a frequency matched control population of 350 healthy siblings.
|
Other: metabolic assessment
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).
Other: questionnaire administration
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.
Other Names:
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Detailed Description:
OBJECTIVES:
Primary
- Determine the manifestations of metabolic syndrome (MS) in children and adolescents who are survivors of childhood cancer (CCS).
- Compare the prevalence of MS in CCS to that of matched healthy siblings of similar age and gender.
- Evaluate insulin resistance (as measured by the euglycemic insulin clamp) in CCS and compare to that of healthy siblings of similar age and gender.
- Assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of the MS that may be altered in the CCS ( e.g., growth-hormone secretion, adipokines [adiponectin, leptin], inflammatory mediators [e.g., interleukin-6], tumor necrosis factor-α, and C-reactive protein).
- Obtain dietary and physical activity assessments of CCS and healthy siblings.
Secondary
- Explore demographic (age at treatment, sex-specific differences) and treatment-related factors (exposures and dose-related associations with chemotherapeutic agents, radiation, steroids) as potential correlates with insulin resistance, vascular function, and MS in CCS.
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.
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- Subjects must be survivors of childhood cancer, treated at Fairview-University Medical Center or Children's Hospitals and Clinics of Minneapolis and St Paul or siblings of survivors.
- Subjects will be 9-17 years old at the time of their visit.
- Subjects who are cancer survivors must have survived childhood cancer for a minimum of 5 years and be in remission.
Exclusion Criteria:
- Eligibility will not be restricted by race or sex.
- Any women currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing.
- Subjects who underwent hematopoietic cell transplant (HCT) are not eligible for this study.
Contacts and Locations| United States, Minnesota | |
| University of Minnesota Children's Hospital - Fairview | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | Julia Steinberger, MD, MS | Masonic Cancer Center, University of Minnesota |
More Information
Additional Information:
No publications provided
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00920738 History of Changes |
| Other Study ID Numbers: | 2003NT064, 0411M65666 |
| Study First Received: | June 12, 2009 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Masonic Cancer Center, University of Minnesota:
|
metabolic syndrome cancer survivor childhood soft tissue sarcoma unspecified childhood solid tumor, protocol specific childhood acute lymphoblastic leukemia childhood chronic myelogenous leukemia childhood Hodgkin lymphoma childhood non-Hodgkin lymphoma childhood acute myeloid leukemia/other myeloid malignancies chronic lymphocytic leukemia childhood brain stem glioma |
childhood cerebellar astrocytoma childhood cerebral astrocytoma/malignant glioma childhood choroid plexus tumor childhood craniopharyngioma childhood embryonal tumor childhood ependymoma childhood oligodendroglioma childhood pineal parenchymal tumor childhood mixed glioma childhood subependymal giant cell astrocytoma childhood visual pathway and hypothalamic glioma |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Nervous System Neoplasms Central Nervous System Neoplasms Metabolic Syndrome X Sarcoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Neoplasms by Site Nervous System Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Neoplasms, Connective and Soft Tissue |
ClinicalTrials.gov processed this record on June 18, 2013