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

December 10, 2008
June 22, 2011
February 2007
October 2010   (final data collection date for primary outcome measure)
Hepatic iron content as measured by R2 MRI. [ Time Frame: Pre-HSCT and Day 100 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00806715 on ClinicalTrials.gov Archive Site
Genetic determinants of iron overload- HFE status. [ Time Frame: Pre-HSCT ] [ Designated as safety issue: No ]
Same as current
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Iron Overload in Stem Cell Transplant Recipients
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Peripheral blood specimens.

Non-Probability Sample

Children undergoing allogeneic stem cell transplantation.

Iron Overload
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
October 2010
October 2010   (final data collection date for primary outcome measure)
  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).
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00806715
DFCI 07-004
No
Deborah Chirnomas, MD, Dana-Farber/Children's Hospital Cancer Center
Children's Hospital Boston
  • Dana-Farber Cancer Institute
  • Lance Armstrong Foundation
Not Provided
Children's Hospital Boston
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP