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NCT00806715 Clinical Trial

Iron Overload in Stem Cell Transplant Recipients

Iron Overload Clinical Trial

Official title:
Impact of Iron Overload in Pediatric Patients Undergoing Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00806715
Other study ID # DFCI 07-004
Secondary ID
Status Completed
Phase
First received December 10, 2008
Last updated March 22, 2018
Start date February 2007
Est. completion date October 2010

Study information
Verified date June 2011
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 5 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Boston Children’s Hospital Dana-Farber Cancer Institute, Lance Armstrong Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatic iron content as measured by R2 MRI. Pre-HSCT and Day 100
Secondary Genetic determinants of iron overload- HFE status. Pre-HSCT
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