NCT00806715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 26, 2018

Status Verified

June 1, 2011

Enrollment Period

3.7 years

First QC Date

December 10, 2008

Last Update Submit

March 22, 2018

Conditions

Iron Overload

Keywords

hemochromatosisIron overloadStem cell transplantPediatricsPediatric Stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Hepatic iron content as measured by R2 MRI.

    Pre-HSCT and Day 100

Secondary Outcomes (1)

  • Genetic determinants of iron overload- HFE status.

    Pre-HSCT

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children undergoing allogeneic stem cell transplantation.

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood specimens.

MeSH Terms

Conditions

Iron OverloadHemochromatosis

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMetal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

February 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 26, 2018

Record last verified: 2011-06

Locations

US(1)