Iron Overload in Pediatric Oncology Patients

• ClinicalTrials.gov Identifier: NCT01034072
• Recruitment Status: Completed
• First Posted: December 17, 2009
• Last Update Posted: April 11, 2018
• Sponsor: Northwell Health
• Collaborator: Novartis
• Information provided by (Responsible Party): Jonathan Fish, Northwell Health

Study Description

Brief 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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 75 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of Iron Overload in Pediatric Oncology and Hematopoietic Stem Cell Transplant Patients
• Actual Study Start Date: December 2009
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• 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

Locations

United States, New York

Feinstein Institute for Medical Research

Manhasset, New York, United States, 11030

Sponsors and Collaborators

Northwell Health

Novartis

Investigators

• Principal Investigator: Jonathan Fish, MD; Feinstein Institute for Medical Research

More Information

• Responsible Party: Jonathan Fish, Physician, Northwell Health
• ClinicalTrials.gov Identifier: NCT01034072
• Other Study ID Numbers: 09-116
• First Posted: December 17, 2009
• Last Update Posted: April 11, 2018
• Last Verified: April 2018

Additional relevant MeSH terms:

Iron Overload; Iron Metabolism Disorders; Metabolic Diseases