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Iron Overload in Pediatric Oncology Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Feinstein Institute for Medical Research.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034072
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by:
Feinstein Institute for Medical Research
  Purpose
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.

Condition
Iron Overload

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Evaluation of Iron Overload in Pediatric Oncology and Hematopoietic Stem Cell Transplant Patients

Resource links provided by NLM:


Further study details as provided by Feinstein Institute for Medical Research:

Primary Outcome Measures:
  • Prevalence of iron overload in pediatric oncology and transplant patients post-treatment. [ Time Frame: 1-10 years ]

Estimated Enrollment: 160
Study Start Date: October 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   78 Months to 25 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034072


Contacts
Contact: Jennifer Eng, MD (718) 470-7656 Jeng1@nshs.edu

Locations
United States, New York
Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Feinstein Institute for Medical Research
Novartis
Investigators
Principal Investigator: Jennifer Eng, MD Feinstein Institute for Medical Research
  More Information

Responsible Party: Jennifer Eng, MD, Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier: NCT01034072     History of Changes
Other Study ID Numbers: 09-116
First Submitted: December 16, 2009
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases