Iron Overload in Stem Cell Transplant Recipients

Impact of Iron Overload in Pediatric Patients Undergoing Stem Cell Transplantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00806715

Enrollment

Registered

2008-12-11

Start date

2007-02-28

Completion date

2010-10-31

Last updated

2018-03-26

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

Conditions

Iron Overload

Keywords

hemochromatosis, Iron overload, Stem cell transplant, Pediatrics, Pediatric Stem cell transplant

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Undergoing allogeneic HSCT for malignant or non-malignant conditions 2. Age greater than or equal to 5 years 3. Able to undergo MRI without a need for general anesthesia 4. No metal implants 5. 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).

Design outcomes

Primary

Measure	Time frame
Hepatic iron content as measured by R2 MRI.	Pre-HSCT and Day 100

Secondary

Measure	Time frame
Genetic determinants of iron overload- HFE status.	Pre-HSCT

Countries

United States

Outcome results