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

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT00897078

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

19.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Other: laboratory biomarker analysis Other: medical chart review Other: metabolic assessment Other: questionnaire administration Procedure: assessment of therapy complications

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.

Study Design

Study Type:

Observational

Actual Enrollment :

39 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Health Effects After Leukemia (HEAL) Research Study

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Outcome Measures

Primary Outcome Measures

Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers [2009-2011]
Host- and treatment-related risk factors for MS [2009-2011]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee	United States	37064
2	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838