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

Vanderbilt University

Status: Completed

Conditions: Leukemia

Treatments: Other: laboratory biomarker analysis; Procedure: assessment of therapy complications; Other: metabolic assessment; Other: medical chart review; Other: questionnaire administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00897078

CDR0000635797

VU-VICC-PED-0888

081208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: Accepts Healthy Volunteers

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