Sickle Cell Anemia - A Comparative Study Between Three Ethnical Communities, a Multicenter Study
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|ClinicalTrials.gov Identifier: NCT01905787|
Recruitment Status : Active, not recruiting
First Posted : July 23, 2013
Last Update Posted : October 31, 2019
|Condition or disease|
|Sickle Cell Anemia Sickle Cell β+ or β0 Thalassemia|
Group 1 - Emek group - (EMC): 100 patients will be included in the study, including Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+ patients will be included).
Group 2 - Dana group - (DMC): 50 patients will be included in the study. Group 3 - Schneider group - (ShMC): 50 patients will be included in the study. Group 4 - Detroit group - (WYUMC): 100 patients will be included in the study, Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+) will be included).
Patients with Sickle cell hemoglobin C (SC) and Sickle cell hemoglobin D (SD) disease will not be included as part of the study analysis due to the small numbers of patients expected, but the investigators are encouraged to report the data of those patients for further analysis.
Age: No age limits, patients can be included since diagnosis till age 40 since teenagers and young adults are often treated at pediatric hematology units.
Gender: Males and Females will be included in the study. Pregnant patients: Pregnancy will not be considered as exclusion criteria. Data about pregnancy under Hydroxyurea treatment both in females and in males should be included, including malformations in the offspring. It needs to be emphasized that the recommendation to the patients in both sexes is to stop Hydroxyurea treatment at last three months before conception.
Data collection: Data will be collected from the medical files. Demographic and family history and laboratory findings at diagnosis will be included.
Genetic mutations of the β globin gene in patients with Sickle Cell β thalassemia will be included if previously analyzed and recorded in medical files. Also α globin mutations and SCA haplotypes will be included if they were previously analyzed and are part of the data already present in the medical files.
Further genetic analysis including β and α globin mutations, haplotypes and xmn1 polymorphism will be included in an extension study but those analysis are not an integral part of this initial study unless they were performed before this present study.
Clinical complaints from the last 10 years will be summarized. Iron chelation and Hydroxyurea treatment given in the last 10 years will be summarized.
Complications that were diagnosed at any age will also be recorded.
- Patients without sufficient data at the medical files due to lack of regular follow up will be excluded.
- Patients that give explicit refuse in participation.
- All the patients currently treated and followed up at the centers in Israel will be included.
- A similar number of patients at same age range and same diagnosis will be included from the whole cohort at Detroit MC. Since at Detroit MC a significant larger number of patients, the criteria for patient's selection at this center will be a cohort matched for gender and age to the Israel patients.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Sickle Cell Anemia - A Comparative Study Between Three Ethnical Communities, a Multicenter Study. Clinical and Genetic Characteristics of Sickle Cell Anemia (SCA) Patients in Three Different Communities.|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Group 2 - Dana group
50 patients will be included in the study.
Group 3 - Schneider group
50 patients will be included in the study
Group 4 - Detroit group
100 patients will be included in the study, Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+) will be included).
Group 1 - Emek group
100 patients will be included in the study, including Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+ patients will be included).
- Clinical comparative study between four different Sickle Cell Populations [ Time Frame: 5 years ]Clinical events during the observational period including crises, blood transfusions requirements and hospitalizations.
- Clinical severity and laboratory results related to the Sickle Cell disease [ Time Frame: 5 years ]Laboratory analysis results (Blood count, Hgb F and tests related to hemolysis) will be compared between the different groups
- Retrospective summary to the response to Hydroxyurea Therapy [ Time Frame: 5 years ]From all the groups patients treated by hydroxyurea will be compared between them and between treated patients to patients that did not receive hydroxyurea in terms of clinical events
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): NCT01905787
|United States, Michigan|
|Children's Hospital of Michigan, Detroit Medical Center - Wayne State University|
|Detroit, Michigan, United States|
|Pediatric Hematology Unit HaEmek Medical Center|
|Afula, Israel, 18101|
|Pediatric Hematology Unit - Schneider Children's Hospital - Beilinson Medical Center|
|Petah Tikva, Israel|
|Pediatric Hematology Unit - Dana Children's Hospital - Ichilov Medical Center|
|Tel Aviv, Israel|