Clinical trial NCT00897078: Study of Metabolic Syndrome in Young Patients Who Are Acute Lymphoblastic Leukemia Survivors and Their Healthy Siblings
Official title: Health Effects After Leukemia (HEAL) Research Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: cancer survivor
healthy, no evidence of disease
long-term effects secondary to cancer therapy in children
childhood acute lymphoblastic leukemia in remission
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 39
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers
timeFrame: 2009-2011
measure: Host- and treatment-related risk factors for MS
timeFrame: 2009-2011
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Jill Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References: