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NCT01913548 · ClinicalTrials.gov registry record
Multi-Center Study of Iron Overload: Survey Study (MCSIO)
A clinical trial of Sickle Cell Disease and Thalassemia, sponsored by UCSF Benioff Children's Hospital Oakland.
- Completed
- Registry status
- 423
- Enrollment target
- 8
- Study locations
NCT01913548: Completed study of Sickle Cell Disease and Thalassemia, sponsored by UCSF Benioff Children's Hospital Oakland.
NCT01913548 is a study of Sickle Cell Disease and Thalassemia that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 423 participants, above the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (45% higher). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01913548, a study of Sickle Cell Disease and Thalassemia, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.
- COMPLETED
- Registry status
- 423 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to demonstrate that a sufficient number of iron-overloaded thalassemia (THAL), Sickle Cell Disease (SCD)and Diamond Blackfan Anemia (DBA) populations with similar duration of chronic transfusion, and age at start of transfusions would be available for a confirmatory study. The study will examine the hypothesis that a chronic inflammatory state in SCD leads to hepcidin- and cytokine-mediated iron withholding within the RES (reticuloendothelial system), lower plasma NTBI (non-transferrin bound iron) levels, less distribution of iron to the heart in SCD.
Primary Outcome
Patients with similar duration of chronic transfusion and age at onset of chronic transfusion therapy will be identified from 10 participating centers. Detailed information on iron burden and transfusion, medical, and chelation histories will be obtained in order to establish a cohort of patients that could be available for a future powered study of extra-hepatic iron deposition and underlying biochemical mechanisms.
Conditions Studied
Study Locations (8)
Other
- Universitätsklinikum Hamburg-Eppendorf - Hamburg-Eppendorf
- UCL Cancer Institute - London
California
- Children's Hospital & Research Center Oakland - Oakland
Georgia
- Georgia Regents University - Augusta
Illinois
- Children's Memorial Hospital - Chicago
North Carolina
- Adult Comprehensive Sickle Cell Center, Duke University Medical Center - Durham
Pennsylvania
- Thomas Jefferson SCD Program - Philadelphia
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2010-03-31 |
| Est. Completion | 2013-10-31 |
What the finished NCT01913548 record still lists
NCT01913548 is an observational study that tracks outcomes without assigning an intervention. The registered 423 participants enrollment target is mid-sized for trials with a published cap, above the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (45% higher).
The record links to 3 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01913548 lists 8 locations in 7 states (Other, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT01913548 about?
NCT01913548 is a clinical study titled "Multi-Center Study of Iron Overload: Survey Study (MCSIO)". The purpose of this study is to demonstrate that a sufficient number of iron-overloaded thalassemia (THAL), Sickle Cell Disease (SCD)and Diamond Blackfan Anemia (DBA) populations with similar duration of chronic transfusion, and age at start of transfusions would be available for a confirmatory stud...
What is the current status of trial NCT01913548?
This trial is currently completed. The enrollment target is 423 participants. The study started on 2010-03-31. Estimated completion is 2013-10-31.
What conditions does trial NCT01913548 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Thalassemia, Diamond-Blackfan Anemia.
Who is sponsoring clinical trial NCT01913548?
This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01913548 being conducted?
This trial has 8 study locations across California, Georgia, Illinois, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01913548's enrollment target sits among peer trials
423 11th of 213 higher than 203 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
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