Iron Overload in Pediatric Oncology Patients

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

Study Overview

• Status: Completed
• Conditions: Iron Overload

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of iron overload in pediatric oncology and transplant patients post-treatment.	Prevalence of iron overload in pediatric oncology and transplant patients post-treatment.	1-10 years

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Novartis
• Investigators: Principal Investigator: Jonathan Fish, MD, Feinstein Institute for Medical Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2009
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: December 16, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (ESTIMATE): December 17, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Overload
• Other Study ID Numbers: 09-116