Adipokines as Predictors of the Metabolic Syndrome in ALL Survivors

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00566566
Collaborator
(none)
150
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: sample without DNA

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Official Title:
Adipocytokines as Predictors of the Metabolic Syndrome in Survivors of Childhood Acute Lymphoblastic Leukemia
Study Start Date :
Jan 1, 2008
Anticipated Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
1

ALL survivors 5 years after completion of treatment, during routine medical follow up

Other: sample without DNA
family history, anthropometric measurements and blood sampling

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ALL diagnosis

    • five years after completion of treatment

    • leukemia free during research

    Exclusion Criteria:
    • ongoing chemotherapy and radiotherapy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • Principal Investigator: Yael Weintraub, MD, Tel Aviv University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00566566
    Other Study ID Numbers:
    • SHEBA-07-4861-YW-CTIL
    First Posted:
    Dec 3, 2007
    Last Update Posted:
    Dec 3, 2007
    Last Verified:
    Nov 1, 2007

    Study Results

    No Results Posted as of Dec 3, 2007