Iron Overload in Stem Cell Transplant Recipients

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Lance Armstrong Foundation
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00806715
First received: December 10, 2008
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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
Iron Overload

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Iron Overload in Pediatric Patients Undergoing Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Hepatic iron content as measured by R2 MRI. [ Time Frame: Pre-HSCT and Day 100 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Genetic determinants of iron overload- HFE status. [ Time Frame: Pre-HSCT ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Peripheral blood specimens.


Enrollment: 38
Study Start Date: February 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806715

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

No publications provided

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
Study First Received: December 10, 2008
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014