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Study of Metabolic Syndrome in Young Patients Who Are Acute Lymphoblastic Leukemia Survivors and Their Healthy Siblings

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00897078
First received: May 9, 2009
Last updated: January 3, 2011
Last verified: January 2011
History of Changes
  Purpose

RATIONALE: Gathering information about metabolic syndrome from young patients who have survived acute lymphoblastic leukemia (ALL) may help doctors learn more about the disease.

PURPOSE: This phase I trial is studying the metabolic syndrome in young patients who have survived acute lymphoblastic leukemia and in healthy sibling volunteers.


Condition Intervention Phase
Leukemia
 Other: laboratory biomarker analysis
Other: medical chart review
Other: metabolic assessment
Other: questionnaire administration
Procedure: assessment of therapy complications
 Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Health Effects After Leukemia (HEAL) Research Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers [ Time Frame: Not specified ] [ Designated as safety issue: No ]
  • Host- and treatment-related risk factors for MS [ Time Frame: Not specified ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Banked DNA


Enrollment: 39
Study Start Date: January 2009
Estimated Study Completion Date: October 2014
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: laboratory biomarker analysis
    Not specified
    Other Name: none noted
    Other: medical chart review
    not specified
    Other Name: none noted
    Other: metabolic assessment
    not specified
    Other Name: none noted
    Other: questionnaire administration
    will be obtained at a single clinic visit
    Other Name: none noted
    Procedure: assessment of therapy complications
    not specified
    Other Name: none noted
Detailed Description:

OBJECTIVES:

  • Determine the prevalence of the metabolic syndrome (MS) and its component traits (i.e., obesity, hypertension, dyslipidemia, and insulin resistance) in survivors of childhood acute lymphoblastic leukemia and in healthy sibling volunteers.
  • Identify host- and treatment-related risk factors for MS.

OUTLINE: This is a multicenter study.

Patients' medical charts are reviewed and patients undergo anthropometric measuring (height and weight for BMI calculation and waist and hip circumferences) and blood pressure testing. Patients also complete questionnaires on their physical activity, diet, and family history over 30-45 minutes. Blood is collected to measure cytokines (e.g., adiponectin, leptin, interleukin-6, and C-reactive protein), fasting glucose, and fasting insulin.

Healthy volunteers undergo anthropometric measuring and blood pressure testing (if they are seen in the clinic). They also complete a baseline medical history and questionnaires on their physical activity and diet.

  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A minimum target accrual at each institution is 25 subjects for each treatment modality and 25 siblings, for a total of 75 study participants at VCH. An attempt will be made to approach equal numbers of male and female survivors.

Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS:

  • Meets one of the following eligibility criteria:

    • Childhood acute lymphoblastic leukemia survivor

      • Less than 22 years old at diagnosis

      • Treated from 1990-2007 at one of the following locations:

        • Fred Hutchinson Cancer Research Center and/or Children's Hospital and Regional Medical Center in Seattle, WA
        • Vanderbilt Children's Hospital in Nashville, TN

      • Meets 1 of the following treatment criteria:

        • Completed conventional therapy ≥ 11 months ago and in first complete remission
        • Received an allogeneic hematopoietic cell transplantation ≥ 11 months ago and in complete remission
      • No evidence of recurrent disease

    • Healthy volunteer

      • Full sibling of enrolled cancer survivor
      • Age 8-21 (if more than 1 eligible sibling, sibling of closest age is preferred)
      • No history of cancer

PATIENT CHARACTERISTICS:

  • Able to speak, read, and write English

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No active treatment for graft-vs-host disease

Exclusion Criteria:

  • Lack of ability to speak, read, and write English
  • Active treatment for graft versus host disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897078

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jill Simmons, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jill Simmons, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00897078     History of Changes
Other Study ID Numbers: CDR0000635797, VU-VICC-PED-0888, 081208
Study First Received: May 9, 2009
Last Updated: January 3, 2011
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
cancer survivor
healthy, no evidence of disease
long-term effects secondary to cancer therapy in children
childhood acute lymphoblastic leukemia in remission

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013