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CompletedNCT01034072Updated Apr 11, 2018

Iron Overload in Pediatric Oncology Patients

An observational study in Iron Overload, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 78 Months to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-11.

Sponsored by Northwell Health · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
75
Ages
78 Months to 25 Years
Sex
All
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Study summary

The purpose of this study is to evaluate for iron overload in pediatric oncology and transplant patients who have completed their treatment between one to ten years ago.

Read the detailed description

Long term survivors of childhood cancer, are a distinct group requiring specific follow-up in order to enhance their quality of life. Studies have shown that many of these patients will go on to develop chronic issues within different organ systems. Because of the iron burden of the frequent transfusions required to care for these patients, iron overload may indeed be one of the problems these survivors potentially face. Research primarily in thalassemia and bone marrow transplant patients who were extensively transfused has shown that iron overload can have a significant impact on their overall health. Complications from increased iron burden can include growth retardation, gonadal dysfunction, hypothyroidism, impaired glucose metabolism, cardiac arrhythmias and failure, hepatic fibrosis and cirrhosis, and increased susceptibility to infections. However all of these conditions related to iron overload can be prevented with the use of either phlebotomy or chelation therapy. Based on this knowledge, our objective is to determine if pediatric oncology and transplant patients heavily supported with transfusions develop consequential biochemical and clinical evidence of iron overload.

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Conditions studied

  • Iron Overload

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In context

Iron Overload

164 studies on the registry are indexed under Iron Overload; 9 are open to participants now.

This study's enrollment of 75 is close to the median of 80 across 48 observational studies indexed under Iron Overload.

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Lead sponsor

Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.

Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
78 Months to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients one to ten years post chemotherapy for Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, AML, or neuroblastoma and patients post-transplant for any malignancy.

Inclusion criteria

  • Patients six and a half to twenty five years of age with a history of acute myelogenous leukemia, rhabdomyosarcoma, Ewing sarcoma, osteosarcoma, and neuroblastoma who have completed their treatment or received their last packed red blood cell transfusion at least one year prior to enrollment (which ever occurred later) and are one to ten years post-treatment.
  • Patients six and a half to twenty five years of age who have undergone hematopoietic stem cell transplant for any malignancy and are at least one year from their last transfusion or transplant date prior to enrollment (which ever occurred later) and are one to ten years post-transplant.
  • Patients who were treated at Schneider Children's Hospital or at Children's Hospital of Philadelphia.

Exclusion criteria

Exclusion Criteria:

  • Patients who have clinical evidence of chronic graft vs. host disease of skin, liver or gastrointestinal tract.
  • Patients with a chronic infection (viral hepatitis), liver disease (fibrosis, cirrhosis), or a history of radiation to the liver.
  • Patients who cannot have an MRI due to metallic implants (i.e. pacemakers, prosthetic valves, etc.)
  • Patients who are pregnant.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
75 participants (actual)
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What researchers measure

Primary outcomes

  1. Prevalence of iron overload in pediatric oncology and transplant patients post-treatment.

    Prevalence of iron overload in pediatric oncology and transplant patients post-treatment.

    Time frame: 1-10 years

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Study locations

1 site
  • Feinstein Institute for Medical Research
    Manhasset, New York 11030, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01034072
Lead sponsor
Northwell Health
Collaborators
Novartis
Responsible party
Jonathan Fish (Physician, Northwell Health) — Principal investigator
First posted
Dec 17, 2009
Start date
Dec 2009
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Apr 11, 2018

Study contacts

Jonathan Fish, MD
principal investigator · Feinstein Institute for Medical Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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