Metabolic Syndrome in Childhood Cancer Survivors

NCT00920738 | Completed DMC

• 2 other identifiers: 2003NT0640411M65666
• Study Type: observational
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain and Central Nervous System Tumors; Leukemia; Lymphoma; Metabolic Syndrome; Sarcoma

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS

  Day 1 and Day 2

Study Arms (2)

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; Other: questionnaire administration

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; Other: questionnaire administration

Interventions

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).

Cancer Survivors; Healthy Siblings of Cancer Survivor

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.

Also known as: MAQA, AQA

Cancer Survivors; Healthy Siblings of Cancer Survivor

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Children's Hospital - Fairview

Minneapolis, Minnesota, 55455, United States

Location

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.

MeSH Terms

Conditions

Central Nervous System Neoplasms; Leukemia; Lymphoma; Metabolic Syndrome; Sarcoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Astrocytoma; Choroid Plexus Neoplasms; Familial ependymoma; Oligodendroglioma; Optic Nerve Glioma

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms, Connective and Soft Tissue; Leukemia, Lymphoid; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases

Study Officials

• Julia Steinberger, MD, MS

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: April 1, 2005
• Primary Completion: July 1, 2010
• Study Completion: June 1, 2011
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

US (1)