ThalassemiaNCT00481221
Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter
An observational study of Thalassemia and Iron Deficiency, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 50 years, women only
- Conditions the study is for
- Thalassemia, Iron Deficiency
- What is being tested?
- Observation of results from laboratory tests
- Type of treatment
- Surgery or procedure
- How many people
- 30,000 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2007to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: All pregant women attending to the Mother's and Child stations in northern Israel
Who may be able to join
- Blood count and Hgb electrophoresis analysis received from pregnant women send for screening for thalassemia.
Who cannot join
- Age below 17 yrs and older than 50 yrs.
- Sever anemia with hgb level below 8 gr/dl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter. A Clinical Retrospective Study.
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.
Read more
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.
- Conditions
- Thalassemia, Iron Deficiency
- Being tested
- Observation of results from laboratory tests
- Keywords
- Thalassemia, Iron Deficiency, Carrier screening
- Medical subject headings
- Thalassemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of results from laboratory testsProcedure or surgery
Laboratory data summary only
| Study group | Role | What they receive |
|---|---|---|
| 1 | Screened pregnant women Receives: Procedure: Observation of results from laboratory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startMar 2007
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
- Investigators
- Ariel Koren, MD, Study director, Pediatric Hematology Unit, Ha'Emek Medical CenterIdit Koren, Medical Student, Principal investigator, Pediatric Hematology Unit - Ha'Emek Medical CenterCarina Levin, MD, Study chair, Pediatric Dpt B - Ha'Emek Medical CenterLuci Zalman, PhD, Study chair, Hematology Laboratory - HaEmek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481221
- Sponsor's protocol ID
- 5210906.EMC
- Status last verified
- Oct 2019
- First submitted
- 31 May 2007
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter. A Clinical Retrospective Study.
- ClinicalTrials.gov ID
- NCT00481221
- Acronym / sponsor ID
- 5210906.EMC
- Conditions
- Thalassemia, Iron Deficiency
- Keywords
- Thalassemia, Iron Deficiency, Carrier screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Observation of results from laboratory testsScreened pregnant women |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All pregant women attending to the Mother's and Child stations in northern Israel
Key inclusion criteria (1 listed)
- Blood count and Hgb electrophoresis analysis received from pregnant women send for screening for thalassemia.
Key exclusion criteria (2 listed)
- Age below 17 yrs and older than 50 yrs.
- Sever anemia with hgb level below 8 gr/dl.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of results from laboratory testsLaboratory data summary only | Procedure or surgery | 1 |
Primary outcome
Detection of β Thalassemia Carriers by Red Cell Parameters
Time frame: One year
Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the Automatic blood count counter using mathematics formula
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Koren, MD study director
Pediatric Hematology Unit, Ha'Emek Medical Center
Idit Koren, Medical Student principal investigator
Pediatric Hematology Unit - Ha'Emek Medical Center
Carina Levin, MD study chair
Pediatric Dpt B - Ha'Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia and Iron Deficiency, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of β Thalassemia Carriers by Red Cell Parameters (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.