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NCT01158794 · ClinicalTrials.gov registry record
Genes Influencing Iron Overload State
A clinical trial of Sickle Cell Disease and Thalassemia, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT01158794 is a study of Sickle Cell Disease and Thalassemia that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 50 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01158794, a study of Sickle Cell Disease and Thalassemia, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Iron overload, which can be defined operationally as too much iron in the body, develops as a consequence of too many blood transfusions given, or due to genetic defects hereditary hemochromatosis). Iron accumulates in several organs in the body, such as the heart, liver, endocrine glands (pancreas, thyroid, etc.), and spleen. Excessive iron can damage organs and may even cause death. Iron overload needs to be appropriately monitored and treated to avoid unnecessary morbidity and mortality. The present study, GENIOS, proposes to test prospectively the hypothesis that genetic modifiers influence the iron overload status of patients receiving transfusions. To test this hypothesis, the study will perform genetic studies to investigate possible genetic influences for iron accumulation in the body and will study iron accumulation not only in the liver, but also in the heart, pancreas, kidneys, and spleen. In addition: the study will investigate if these same genes have any role during treatment of iron overload, in other words, if certain genetic mutations will influence how iron exits the body. This study will also investigate how substances that are known to control the trafficking of iron in and out of the body and its damaging effects to the tissues (hepcidin and non transferrin-bound iron) are linked to the accumulation of iron in the heart and liver. Iron in the body will be measured by R2\*MRI and no liver biopsies will be required. Genetic studies will be done by specialized tests using peripheral blood DNA. Iron accumulates differently in different people and in different organs of the body. Some people accumulate iron faster than others, even when receiving the same number of blood transfusions
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-09-21 |
| Est. Completion | 2019-04-17 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01158794
The ClinicalTrials.gov registry entry for NCT01158794 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (83% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01158794 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT01158794 about?
NCT01158794 is a clinical study titled "Genes Influencing Iron Overload State". Iron overload, which can be defined operationally as too much iron in the body, develops as a consequence of too many blood transfusions given, or due to genetic defects hereditary hemochromatosis). Iron accumulates in several organs in the body, such as the heart, liver, endocrine glands (pancreas,...
What is the current status of trial NCT01158794?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2010-09-21. Estimated completion is 2019-04-17.
What conditions does trial NCT01158794 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Thalassemia, Marrow Aplasia.
Who is sponsoring clinical trial NCT01158794?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01158794 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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