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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jill Simmons, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00897078
First received: May 9, 2009
Last updated: June 11, 2013
Last verified: June 2013

May 9, 2009
June 11, 2013
January 2009
October 2011   (final data collection date for primary outcome measure)
  • Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]
  • Host- and treatment-related risk factors for MS [ Time Frame: 2009-2011 ] [ Designated as safety issue: No ]
  • Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers [ Designated as safety issue: No ]
  • Host- and treatment-related risk factors for MS [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897078 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Metabolic Syndrome in Young Patients Who Are Acute Lymphoblastic Leukemia Survivors and Their Healthy Siblings
Health Effects After Leukemia (HEAL) Research Study

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Banked DNA

Non-Probability Sample

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.

Leukemia
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
8 Years to 21 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00897078
CDR0000635797, VU-VICC-PED-0888, 081208
Yes
Jill Simmons, Vanderbilt University
Vanderbilt University
National Cancer Institute (NCI)
Principal Investigator: Jill Simmons, MD Vanderbilt-Ingram Cancer Center
Vanderbilt University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP