Iron Overload in Stem Cell Transplant Recipients | NCT00806715

Studies
Iron Overload in Stem Cell Transplant Recipients

NCT00806715

Sponsor

Boston Children's Hospital

Status

Completed

Last Update Posted

Mar 26, 2018Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Iron Overload

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Dec 10, 2008

First Submission Date that Met QC Criteria

Dec 10, 2008

First Posted Date

Dec 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2018

Last Update Posted Date

Mar 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Deborah Chirnomas, Instructor, Boston Children's HospitalPrincipal Investigator

Lead Sponsor

Boston Children's HospitalOTHER

Collaborators

Name	Class
Dana-Farber Cancer Institute	OTHER
Lance Armstrong Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

38Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Children undergoing allogeneic stem cell transplantation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Boston		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D019190	Iron Overload
D006432	Hemochromatosis

Ancestor Terms

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D008664	Metal Metabolism, Inborn Errors

Browse Leaves

Not provided

Browse Branches

Not provided