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Completed

NCT Number: NCT00897078

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

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.

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Key information

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Other names: none noted

medical chart review

Other

Other names: none noted

metabolic assessment

Other

Other names: none noted

Questionnaire Administration

Other

will be obtained at a single clinic visit

Other names: none noted

assessment of therapy complications

Procedure

Other names: none noted

Primary outcomes

  1. Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers

    Time frame: 2009-2011

  2. Host- and treatment-related risk factors for MS

    Time frame: 2009-2011

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Health Effects After Leukemia (HEAL) Research Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 12, 2009
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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