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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
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Red cell transfusions are an important part of supportive cancer therapy. The iron in the transfused blood may build up in the body since the human body has no way to get rid of extra iron. Iron tends to build up in the liver and the heart muscle. It is unknown if iron build-up is present many years after completing cancer therapy. It is also not known if extra iron causes harm to internal organs. Researchers at St. Jude Children's Research Hospital (SJCRH) want to understand if iron build-up (called "iron overload") exists in survivors of leukemia. They also want to know if iron overload can cause injury to your organs if it is present.
Liver iron accumulation has been documented in childhood cancer survivors, however, it is not known if iron associated organ toxicity is contributing to the long-term morbidity that has been well documented among these survivors. This study will investigate the prevalence of iron overload and the association of tissue iron burden with markers of organ dysfunction in leukemia survivors. This study will determine the prevalence of iron overload among long-term leukemia survivors that underwent blood transfusion. This study will use blood and magnetic resonance imaging (MRI) testing to determine iron overload of specified organs. Understanding the prevalence of iron overload could impact surveillance practices in leukemia survivors.
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVES:
Participants will have blood work drawn after an overnight fast during a routine clinic visit. They will also have an electrocardiogram (EKG) and echocardiogram (ECHO) which are often a required part of their annual visit. Magnetic resonance imaging (MRI) exams of the heart, liver, and surrounding abdominal organs will be done on all participants using a method of scanning that involves a closer study of these organs (called R2* MRI).
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of iron overload | Iron overload will be measured by R2*MRI in the liver and T2* in the heart and is defined as R2*MRI value > 3 mg/g and/or T2* MRI <20ms. | On day of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between hepatic, cardiac, and endocrine dysfunction and transfusionally-acquired iron overload | Fisher's Exact test will be performed to examine the relationship of organ dysfunction and iron overload. Then the logistic regression model will be built to evaluate the effect of the iron overload defined by R2* and T2* MRI on the risk of organ dysfunction, respectively, while controlling for the effects of craniospinal radiation and chemotherapeutic agents. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will have been treated at SJCRH for acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) and would have received ≥50 ml/kg of packed red blood cells during their treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Jane Hankins, MD, MS | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D019337 | Hematologic Neoplasms |
| D019190 | Iron Overload |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| On day of enrollment |
| Association between serum ferritin, transferrin saturation, non-transferrin-bound iron, and hepcidin measurements with R2* and T2* MRI-defined iron overload | Logistic regression model will be used to evaluate the association of iron overload status and the above four iron test measurements. | On day of enrollment |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D009371 | Neoplasms by Site |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |