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Sponsor study identifier
observational
30,000
1 country
1
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
β thalassemia is an autosomal recessive hemoglobinopathy and considered as the most widespread genetic mutation. According to the World Health Organization (WHO) between 1.5-7% of the world population are carriers for this disease, and every year 60,000-400,000 birth of new patients are reported. In Israel, the incidence of carriers for β thalassemia is around 20% among the Jewish from Kurdish origin and around 5-10% among the Arab population. β thalassemia is a severe disease which requires many resources, both medical and financial. The disease is expressed by chronic hemolytic anemia which requires regular blood transfusions every 3 weeks. As a result of the blood transfusions and the iron absorption by the digestive tract, those patients suffer from severe hemosiderosis which is the main mortality cause in the disease, mainly in the second decade for life. Daily treatment with iron chelator is required. Moreover, despite the actual treatment, the quality of life of those patients is still low. Therefore the implementation of a prevention program which includes finding an effective and inexpensive way for identifying the β thalassemia carriers is a humanitary and publicly important goal. In β thalassemia carriers, laboratory tests will show hypochromic microcytic anemia. Those findings are similar in iron deficiency anemia, but the RBC number and the RDW are normal in thalassemia carriers. Few researchers tried in the past to determine cutoff point for diagnosis of β thalassemia carriers by different formulas. We used the algorithm SVM (support vector machine) to find a reliable formula that can separate patients with Iron deficiency anemia/ healthy from patients with β thalassemia minor (carriers). This formula can be inserted to any automatic blood counter and search for suspected carriers without deliberately intention and without any further blood test.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 31, 2007
Actual (reported)June 1, 2007
Actual (reported)December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Detection of β Thalassemia Carriers by Red Cell Parameters
Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the Automatic blood count counter using mathematics formula
One year
Screened pregnant women
Laboratory data summary only
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All pregant women attending to the Mother's and Child stations in northern Israel
Pediatric Hematology Unit - HaEmek Medical Center
Afula, 18101, Israel
Ariel Koren, MD
Pediatric Hematology Unit, Ha'Emek Medical Center
Idit Koren, Medical Student
Pediatric Hematology Unit - Ha'Emek Medical Center
Carina Levin, MD
Pediatric Dpt B - Ha'Emek Medical Center
Luci Zalman, PhD
Hematology Laboratory - HaEmek Medical Center
First Submitted
May 31, 2007
First Posted
June 1, 2007
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 31, 2020
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 1, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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