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

June 11, 2013 updated by: Jill Simmons, Vanderbilt University

Health Effects After Leukemia (HEAL) Research Study

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.

Study Overview

Status

Completed

Conditions

Leukemia

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Tennessee
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt-Ingram Cancer Center
  - Nashville, Tennessee, United States, 37064
    - Vanderbilt-Ingram Cancer Center - Cool Springs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of the metabolic syndrome (MS) and its component traits in these patients and in healthy volunteers Time Frame: 2009-2011	2009-2011
Host- and treatment-related risk factors for MS Time Frame: 2009-2011	2009-2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Jill Simmons, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria