Multi-Center Study of Iron Overload: Survey Study (MCSIO)

Completed

Conditions studied: Sickle Cell Disease, Thalassemia, Diamond-Blackfan Anemia

In brief

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.

Key facts

Study ID

NCT01913548

Run by

UCSF Benioff Children's Hospital Oakland

People needed

423

Starts

2010-03-31

Expected to finish

2013-10-31

Last updated by the study team

2020-09-23

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Children's Hospital & Research Center Oakland — Oakland, California, United States
• Georgia Regents University — Augusta, Georgia, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Adult Comprehensive Sickle Cell Center, Duke University Medical Center — Durham, North Carolina, United States
• Thomas Jefferson SCD Program — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Universitätsklinikum Hamburg-Eppendorf — Hamburg-Eppendorf, Germany
• UCL Cancer Institute — London, United Kingdom

Full record on ClinicalTrials.gov

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