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OpenTrials
Completed

NCT Number: NCT01034072

Iron Overload in Pediatric Oncology Patients

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.

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Key information

Age range

78 month–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1-10 years

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

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Novartis

Registry information

Official study title

Evaluation of Iron Overload in Pediatric Oncology and Hematopoietic Stem Cell Transplant Patients

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 17, 2009
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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