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NCT01965171 · ClinicalTrials.gov registry record
Transfusional Iron Overload Among Leukemia Survivors
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 24
- Enrollment target
NCT01965171: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT01965171 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01965171 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
Study Summary
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: * To determine the prevalence of iron overload in the liver \[liver iron concentration (LIC) \>3mg/g using R2\* MRI measurements\] and in the heart (T2\* \<20 ms) among long-term leukemia survivors transfused with ≥50ml/kg of packed red blood cells. SECONDARY OBJECTIVES: * To examine the relationship between hepatic, cardiac, and endocrine dysfunction and transfusionally acquired iron overload as defined by R2\* and T2\* MRI among survivors of pediatric leukemias. * To investigate the association between serum ferritin, transferrin saturation, non-transferrin-bound iron, and hepcidin
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-10-18 |
| Est. Completion | 2017-05 |
What the finished NCT01965171 record still lists
NCT01965171 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01965171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01965171 about?
NCT01965171 is a clinical study titled "Transfusional Iron Overload Among Leukemia Survivors". 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...
What is the current status of trial NCT01965171?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2013-10-18. Estimated completion is 2017-05.
Who is sponsoring clinical trial NCT01965171?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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