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

NCT ID: NCT00897078

Last Updated: 2013-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-10-31

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.

Conditions

Leukemia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

laboratory biomarker analysis

Intervention Type: OTHER

medical chart review

Intervention Type: OTHER

metabolic assessment

Intervention Type: OTHER

questionnaire administration

will be obtained at a single clinic visit

Intervention Type: OTHER

assessment of therapy complications

Intervention Type: PROCEDURE

Other Intervention Names

none noted; none noted; none noted; none noted; none noted

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Jill Simmons

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill Simmons, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

VU-VICC-PED-0888

Identifier Type: -

Identifier Source: secondary_id

081208

Identifier Type: -

Identifier Source: secondary_id

CDR0000635797

Identifier Type: -

Identifier Source: org_study_id