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Iron Overload in Stem Cell Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00806715
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : June 27, 2011
Sponsor:
Collaborators:
Information provided by:

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
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 : February 2007
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Hepatic iron content as measured by R2 MRI. [ Time Frame: Pre-HSCT and Day 100 ]

Secondary Outcome Measures :
  1. Genetic determinants of iron overload- HFE status. [ Time Frame: Pre-HSCT ]

Biospecimen Retention:   Samples With DNA
Peripheral blood specimens.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing allogeneic stem cell transplantation.
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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806715


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Dana-Farber Cancer Institute
Lance Armstrong Foundation
More Information

Responsible Party: Deborah Chirnomas, MD, Dana-Farber/Children's Hospital Cancer Center
ClinicalTrials.gov Identifier: NCT00806715     History of Changes
Other Study ID Numbers: DFCI 07-004
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Boston Children’s Hospital:
hemochromatosis
Iron overload
Stem cell transplant
Pediatrics
Pediatric Stem cell transplant

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases