Iron Overload in Stem Cell Transplant Recipients

March 22, 2018 updated by: Deborah Chirnomas, Boston Children's Hospital

Impact of Iron Overload in Pediatric Patients Undergoing Stem Cell Transplantation

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.

Study Overview

Status

Completed

Conditions

Iron Overload

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children undergoing allogeneic stem cell transplantation.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Genetic determinants of iron overload- HFE status. Time Frame: Pre-HSCT	Pre-HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Dana-Farber Cancer Institute

Lance Armstrong Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria