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Sponsored by: |
HaEmek Medical Center, Israel |
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Information provided by: | HaEmek Medical Center, Israel |
ClinicalTrials.gov Identifier: | NCT00481221 |
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.
Condition | Intervention |
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Thalassemia Iron Deficiency |
Procedure: Observation of results from laboratory tests |
Study Type: | Observational |
Study Design: | Retrospective |
Official Title: | Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter. A Clinical Retrospective Study. |
Estimated Enrollment: | 300 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | June 2007 |
Groups/Cohorts | Assigned Interventions |
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1
Screened pregnant women
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Procedure: Observation of results from laboratory tests
Laboratory data summary only
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Ages Eligible for Study: | 17 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
All pregant women attending to the Mother's and Child stations in northern Israel
Inclusion Criteria:
Exclusion Criteria:
Contact: Ariel Koren, MD | 972-4-6495576 ext 5576 | koren_a@clalit.org.il |
Israel | |
Pediatric Hematology Unit - HaEmek Medical Center | Recruiting |
Afula, Israel, 18101 | |
Contact: Ariel Koren, MD 972-4-6495576 ext 5576 koren_a@clalit.org.il | |
Principal Investigator: Idit Koren, Medical Student |
Study Director: | Ariel Koren, MD | Pediatric Hematology Unit, Ha'Emek Medical Center |
Principal Investigator: | Idit Koren, Medical Student | Pediatric Hematology Unit - Ha'Emek Medical Center |
Study Chair: | Carina Levin, MD | Pediatric Dpt B - Ha'Emek Medical Center |
Study Chair: | Luci Zalman, PhD | Hematology Laboratory - HaEmek Medical Center |
Responsible Party: | Pediatric Hematology Unit - Ha'Emek Medical Center ( Dr Levin Carina ) |
Study ID Numbers: | 5210906.EMC |
Study First Received: | May 31, 2007 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00481221 History of Changes |
Health Authority: | Israel: Ministry of Health |
Thalassemia Iron Deficiency Carrier screening |
Metabolic Diseases Hematologic Diseases Anemia Anemia, Hemolytic Iron Metabolism Disorders Thalassemia Anemia, Iron-Deficiency |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hemoglobinopathies Hemoglobinopathy Metabolic Disorder Iron |
Anemia, Hemolytic, Congenital Metabolic Diseases Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Anemia, Hypochromic |
Anemia Anemia, Hemolytic Iron Metabolism Disorders Thalassemia Anemia, Iron-Deficiency |