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Sponsored by: |
Sheba Medical Center |
Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00566566 |
Background: Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for 25% of all childhood cancers. Peak incidence occurs between 2 to 5 years of age. Modern treatment regimens have improved cure rates from virtually zero (in the 1950's) to current overall survival rates of approximately 80%.The high survival rates have introduced us to novel medical problems as a consequences of the different treatment regimens. No single treatment modality exists today but rather several treatment protocols are accepted worldwide. As such, the population of the childhood ALL survivors differ in their toxic exposure: cranial & spinal radiotherapy, intrathecal and/or systemic chemotherapy and bone marrow transplantation .As the survival rates grow, there are more young adult ALL survivors worldwide susceptible to these late effects of treatment.
Numerous reports have pointed out that this particular group is at increased risk to develop cardiovascular disease (CVD) and diabetes (MS). The metabolic syndrome, i.e hypertension, dyslipidemia, impaired glucose metabolism and obesity, occurs at a younger age than the general population.
Adipocytokines, mediators secreted by adipose tissue, play an important role in the regulation of carbohydrates and lipid metabolism.Changes in serum adipokine levels precede the clinical symptoms.
We aim to identify and assess prevalence of the MS in ALL survivors. We aim to characterize the population at risk to develop DM and CVD prior to overt clinical disease. Characterization will be done by measuring serum adipocytokines and inflammatory cytokine profiles .Biochemical characterization of the group at risk will enable us to intervene in the preventive stage in the future.
Condition | Intervention |
Leukemia Metabolic Syndrome X |
Other: sample without DNA |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Metabolic Syndrome |
ChemIDplus related topics: | Leptin |
Study Type: | Observational |
Study Design: | Cohort, Other |
Official Title: | Adipocytokines as Predictors of the Metabolic Syndrome in Survivors of Childhood Acute Lymphoblastic Leukemia |
Serum leptin, resistin ,adiponectin ,CRP, PAI ,TNF-α, IL-6 will be taken as part of initial blood test screening in patients following an overnight fast. Adiponectin and leptin levels will be determined by RIA (Linco, St. Charles, MO), Insulin, will be determined by chemiluminescent immunometric method (Immulite 2000, Diagnostic Products Corporation, Los Angeles, CA).
Estimated Enrollment: | 150 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2008 |
Groups/Cohorts | Assigned Interventions |
1
ALL survivors 5 years after completion of treatment, during routine medical follow up
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Other: sample without DNA
family history, anthropometric measurements and blood sampling
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Ages Eligible for Study: | 6 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Hematoncological pediatric clinic
Inclusion Criteria:
Exclusion Criteria:
Contact: Bella Bielorai, MD | 972-3-5302692 | Bella.Bielorai@sheba.health.gov.il |
Sheba Medical Center |
Principal Investigator: | Yael Weintraub, MD | Tel Aviv University |
Responsible Party: | Sheba Medical Cener ( Dr. Yael Weintraub ) |
Study ID Numbers: | SHEBA-07-4861-YW-CTIL |
First Received: | November 30, 2007 |
Last Updated: | November 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00566566 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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