NCT00920842

Brief Summary

RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood leukemia who have undergone stem cell transplant may help doctors learn more about the disease and the long-term effects of leukemia treatment. It may also help improve the quality of life for future cancer survivors. PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone stem cell transplant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

6.3 years

First QC Date

June 12, 2009

Last Update Submit

November 29, 2012

Conditions

Cardiovascular ComplicationsLeukemiaLong-term Effects Secondary to Cancer Therapy in ChildrenMetabolic Syndrome

Keywords

metabolic syndromelong-term effects secondary to cancer therapy in childrencardiovascular complicationscancer survivorchildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood chronic myelogenous leukemiajuvenile myelomonocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (10)

  • Comparison of the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) with age- and gender-matched controls

    ≥2 years post-HSCT

  • Comparison of insulin resistance in patients with age- and gender-matched controls

    ≥2 years post-HSCT

  • Correlation between insulin sensitivity and risk factors associated with metabolic syndrome

    ≥2 years post-HSCT

  • Influence of time since transplant on insulin resistance

    ≥2 years post-HSCT

  • Peak growth hormone secretion in patients with insulin resistance and in those without

    ≥2 years post-HSCT

  • Growth hormone deficiency in patients with metabolic syndrome and in those without

    ≥2 years post-HSCT

  • Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity

    ≥2 years post-HSCT

  • Correlation of adiponectin with insulin resistance and central obesity

    ≥2 years post-HSCT

  • Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease

    ≥2 years post-HSCT

  • Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without

    ≥2 years post-HSCT

Eligibility Criteria

Age9 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Childhood leukemia survivors and healthy siblings, 9-21 years of age.

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Survivor of childhood leukemia, meeting all of the following criteria: * 21 years of age and under at diagnosis * Has undergone hematopoietic stem cell transplantation (HSCT) at Fairview University Medical Center or Fred Hutchinson Cancer Research Center ≥ 2 years ago * Disease in remission * Healthy sibling of a childhood leukemia survivor PATIENT CHARACTERISTICS: * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center - Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

LeukemiaMetabolic SyndromeLeukemia, Myelomonocytic, JuvenileLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLeukemia, MyeloidMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • K S Baker, MD, MS

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

April 1, 2005

Primary Completion

July 1, 2011

Study Completion

November 1, 2012

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

US(1)