Iron Overload in Pediatric Oncology Patients

NCT01034072 | Completed

• 1 other identifier: 09-116
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Overload

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 78 Months - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• Novartis: collaborator

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Iron Overload

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jonathan Fish, MD

  Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

US (1)