Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics (STARRING)
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|ClinicalTrials.gov Identifier: NCT03288012|
Recruitment Status : Unknown
Verified August 2018 by Sanquin Research & Blood Bank Divisions.
Recruitment status was: Recruiting
First Posted : September 19, 2017
Last Update Posted : July 19, 2019
|Condition or disease|
|Alloimmunization Sickle Cell Disease|
The main objectives of this study are to study the role of the innate and adaptive immune response in allo-antibody formation and furthermore to identify the genetic and time dependent clinical risk factors on alloimmunization in SCD patients.
Subjects without allo-antibodies, receiving a red blood cell transfusion, will be included in this study. At 5 time points blood will be drawn from these subjects. (T0: Before transfusion, T1: 1 day after transfusion, T2: 1 week after transfusion, T3: 4 weeks after transfusion, T4: 6 months after transfusion).
At each time point specific markers of the immune system will be measured.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics|
|Actual Study Start Date :||September 20, 2017|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- The innate and adaptive immune response of patients with sickle cell disease that form allo-antibodies following erythrocyte transfusion, compared to patients that do not form alloantibodies following erythrocyte transfusion [ Time Frame: 6 months ]Multiple activating and regulatory markers of the innate and adaptive immune system will be measured at the indicated time points and compared between cases and controls
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288012
|Contact: Karin Fijnvandraat, MD PhDfirstname.lastname@example.org|
|Academic Medical Center Amsterdam||Recruiting|
|Contact: Karin Fijnvandraat, PhD +31 02 5123122 email@example.com|
|HagaZiekenhuis||Not yet recruiting|
|Den Haag, Netherlands|
|Contact: Jean Louis Kerkhoffs, PhD|
|Principal Investigator: Jean-Louis Kerkhoffs, PhD|
|Contact: S Schols, MD 0031243618800|
|Contact: Marjon Cnossen, PhD|
|Principal Investigator: Marjon Cnossen, PhD|