Iron OverloadNCT00806715
Iron Overload in Stem Cell Transplant Recipients
An observational study of Iron Overload, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Iron Overload
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children undergoing allogeneic stem cell transplantation.
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Conditions
- Iron Overload
- Keywords
- hemochromatosis, Iron overload, Stem cell transplant, Pediatrics, Pediatric Stem cell transplant
- Medical subject headings
- Iron Overload, Hemochromatosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic iron content as measured by R2 MRI.
Measured: Pre-HSCT and Day 100
Secondary outcomes (1)
Genetic determinants of iron overload- HFE status.
Measured: Pre-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startFeb 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron OverloadStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Lance Armstrong Foundation
- Responsible party
- Principal investigator, Deborah Chirnomas, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806715
- Sponsor's protocol ID
- DFCI 07-004
- Status last verified
- Jun 2011
- First submitted
- 10 Dec 2008
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Iron Overload in Pediatric Patients Undergoing Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00806715
- Acronym / sponsor ID
- DFCI 07-004
- Conditions
- Iron Overload
- Keywords
- hemochromatosis, Iron overload, Stem cell transplant, Pediatrics, Pediatric Stem cell transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Lance Armstrong Foundation
- Study start
- Feb 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children undergoing allogeneic stem cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hepatic iron content as measured by R2 MRI.
Time frame: Pre-HSCT and Day 100
1 secondary outcome
Genetic determinants of iron overload- HFE status.
Time frame: Pre-HSCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Overload, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic iron content as measured by R2 MRI. (time frame: Pre-HSCT and Day 100). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.