Iron Overload in Stem Cell Transplant Recipients

Sponsor

Boston Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00806715

Collaborator

Dana-Farber Cancer Institute (Other), Lance Armstrong Foundation (Other)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to examine the impact of iron overload in patients undergoing a bone marrow transplant. We believe that the iron status in these patients is associated with complications for transplant survivors. We will examine the iron status in these patients by MRI and by screening for mutations in genes known to cause iron overload. We will also determine the levels of hepcidin (a hormone produced in the liver that appears to regulate iron homeostasis) from blood and urine.

Condition or Disease	Intervention/Treatment	Phase
Iron Overload

Study Design

Study Type:

Observational

Actual Enrollment :

38 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Iron Overload in Pediatric Patients Undergoing Stem Cell Transplantation

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Outcome Measures

Primary Outcome Measures

Hepatic iron content as measured by R2 MRI. [Pre-HSCT and Day 100]

Secondary Outcome Measures

Genetic determinants of iron overload- HFE status. [Pre-HSCT]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Undergoing allogeneic HSCT for malignant or non-malignant conditions
Age greater than or equal to 5 years
Able to undergo MRI without a need for general anesthesia
No metal implants
Signed informed consent (by parent if patient is less than 18 years old, or by patient, if he or she is greater than 18 years old).