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

Leukemia Clinical Trial

Official title:

Health Effects After Leukemia (HEAL) Research Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897078
• Other study ID #: CDR0000635797
• Secondary ID: VU-VICC-PED-0888
• Status: Completed
• Phase: Phase 1
• First received: May 9, 2009
• Last updated: June 11, 2013
• Start date: January 2009
• Est. completion date: October 2011

Study information

• Verified date: June 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 21 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• laboratory biomarker analysis
Not specified
• medical chart review
not specified
• metabolic assessment
not specified
• questionnaire administration
will be obtained at a single clinic visit

Procedure:
• assessment of therapy complications
not specified

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers		2009-2011	No
Primary	Host- and treatment-related risk factors for MS		2009-2011	No