Status:
COMPLETED
Multi-Center Study of Iron Overload: Survey Study (MCSIO)
Lead Sponsor:
UCSF Benioff Children's Hospital Oakland
Collaborating Sponsors:
University College London (UCL) Cancer Institute
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Sickle Cell Disease
Thalassemia
Eligibility:
All Genders
16+ years
Brief 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...
Detailed Description
A detailed iron burden, transfusion and chelation history will be obtained from chart review or from participant recall. Iron burden data will include: 1) documentation of liver iron, and 2) average ...
Eligibility Criteria
Inclusion
- 10-20 years of transfusion (defined as 0.2-0.6mg Fe/kg/day exposure with annual ferritin levels greater than 2500 in at least 60% of years of chronic transfusion);
- 0 to 9 years old at the initiation of chronic transfusions; no exchange transfusions in the previous 6 months
- iron overload documented by either liver biopsy, MRI or SQUID with estimated LIC of greater than 7 mg/g dry wt in the previous 6 months or ferritin level greater than 1500mg/dl.
Exclusion
- Patients with HbSC, HbS/β thalassemia
- Pacemaker (active or inactive) or other implanted magnetic devices, severe claustrophobia, or other contraindications to MRI; Unable to remove ferro-magnetic objects from the body in regions to be imaged (e.g., jewelry or piercing)
- Presence of any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment;
- Any chronic inflammatory illness other than the SCD, THAL or DBA;
- Any acute illness within a 14 day period prior to blood sampling;
- Patients receiving intensive chelation in the 6 months prior to enrollment including deferoxamine 24 hours per day, 7 days per week or combination treatment with 2 chelators
- Pregnancy
Key Trial Info
Start Date :
March 31 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2013
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT01913548
Start Date
March 31 2010
End Date
October 31 2013
Last Update
September 23 2020
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
2
Georgia Regents University
Augusta, Georgia, United States, 30912
3
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
4
Adult Comprehensive Sickle Cell Center, Duke University Medical Center
Durham, North Carolina, United States, 27710