Adipokines as Predictors of the Metabolic Syndrome in ALL Survivors

• Conditions: Leukemia; Metabolic Syndrome X
• Interventions: Other: sample without DNA

• Registration Number: NCT00566566
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-11
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Last Update Submitted: 2007-11-30
• Study First Posted: 2007-12-03
• Last Update Posted: 2007-12-03
• Study Start: 2008-01
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• ALL diagnosis
• five years after completion of treatment
• leukemia free during research

Exclusion Criteria

• ongoing chemotherapy and radiotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	sample without DNA	ALL survivors 5 years after completion of treatment, during routine medical follow up