| Home Search Study Topics Glossary |
![]() | ![]() |
| ![]() |
| ![]() |
| ![]() | ![]() | ![]() |
| ![]() | ![]() | ||||||||||||||||||||||||||||||||||||
| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00920842 |
Purpose
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.
| Condition |
|---|
| Cancer Survivor Cardiovascular Complications Leukemia Long-term Effects Secondary to Cancer Therapy in Children Metabolic Syndrome |
| Study Type: | Observational |
| Study Design: |
Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Metabolic Syndrome Following Transplant for Leukemia |
| Estimated Enrollment: | 386 |
| Study Start Date: | April 2005 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 9 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Childhood leukemia survivors and healthy siblings, 9-21 years of age.
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Survivor of childhood leukemia, meeting all of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Washington | |
| Clinical Research Center - Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Paul Hoffmeister 206-667-6723 | |
| Principal Investigator: | K S Baker, MD, MS | Fred Hutchinson Cancer Research Center |
More Information
| Responsible Party: | Fred Hutchinson Cancer Research Center ( K. S. Baker, MD, MS ) |
| ClinicalTrials.gov Identifier: | NCT00920842 History of Changes |
| Other Study ID Numbers: | IR 7141, P30CA077598, UMN-2003NT063, CDR0000642276, IR-6980, FHCRC-2357.00 |
| Study First Received: | June 12, 2009 |
| Last Updated: | May 28, 2010 |
| Health Authority: | United States: Federal Government |
| metabolic syndrome long-term effects secondary to cancer therapy in children cardiovascular complications cancer survivor childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission | childhood chronic
myelogenous leukemia juvenile myelomonocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
| Leukemia Metabolic Syndrome X Neoplasms by Histologic Type Neoplasms | Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |