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

Health Effects After Leukemia (HEAL) Research Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00897078

Enrollment

Registered

2009-05-12

Start date

2009-01-31

Completion date

2011-10-31

Last updated

2013-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERlaboratory biomarker analysis

OTHERmedical chart review

OTHERmetabolic assessment

OTHERquestionnaire administration

will be obtained at a single clinic visit

PROCEDUREassessment of therapy complications

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 21 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026