Clinical trial NCT01034072: Iron Overload in Pediatric Oncology Patients
Official title: Evaluation of Iron Overload in Pediatric Oncology and Hematopoietic Stem Cell Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Overload
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2009-12-17
Enrollment: 75
Sex: ALL
Minimum age (years): 78
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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 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.

Primary outcomes:
measure: Prevalence of iron overload in pediatric oncology and transplant patients post-treatment.
timeFrame: 1-10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Jonathan Fish, MD
role: PRINCIPAL_INVESTIGATOR
References: