Sickle Cell DiseaseNCT00481039
Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel
An observational study of Sickle Cell Disease, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Sickle cell anemia and sickle cell thalassemia are frequent diseases among the israeli arab population. The purpose of this study is to assess the clinical characteristics of the patients in one arab village and the laboratory characteristics in the carriers of this gene based in the screening for pregnant women that… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Medical history and basic laboratory analysis
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- May 2007to Dec 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients diagnosed with abnormal hemoglobin in the bedouin arab village
Who may be able to join
- All the patients that were diagnosed as having sickle cell disease in the specific village and all the population screened for hemoglobinopathies in the same location
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel- An Observational Study
Sickle cell anemia and sickle cell thalassemia are frequent diseases among the israeli arab population. The purpose of this study is to assess the clinical characteristics of the patients in one arab village and the laboratory characteristics in the carriers of this gene based in the screening for pregnant women that is carried out in the population of northern Israel.
The results can be useful in order to institute universal screening for sickle cell anemia in northern Israel.
- Conditions
- Sickle Cell Disease
- Being tested
- Medical history and basic laboratory analysis
- Keywords
- Sickle cell disease, Sickle cell thalassemia, Population screening
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical history and basic laboratory analysisProcedure or surgery
Medical history and basic laboratory analysis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients diagnosed as having abnormal hemoglobin like hemoglobin S and thalassemia in a bedouin village Receives: Procedure: Medical history and basic laboratory analysis |
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 startMay 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Ariel Koren, MD, Study director, Pediatric Hematology Unit, Ha'Emek Medical Centerluci Zalman, Phd, Study chair, Hematology Laboratory - HaEmek Medical CenterTania Flaishman, Student, Principal investigator, Pediatric Dpt B - Ha'Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481039
- Sponsor's protocol ID
- 5311006.EMC
- Status last verified
- Sep 2009
- First submitted
- 31 May 2007
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel- An Observational Study
- ClinicalTrials.gov ID
- NCT00481039
- Acronym / sponsor ID
- 5311006.EMC
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle cell disease, Sickle cell thalassemia, Population screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- 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.
Sickle cell anemia and sickle cell thalassemia are frequent diseases among the israeli arab population. The purpose of this study is to assess the clinical characteristics of the patients in one arab village and the laboratory characteristics in the carriers of this gene based in the screening for pregnant women that is carried out in the population of northern Israel.
The results can be useful in order to institute universal screening for sickle cell anemia in northern Israel.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Medical history and basic laboratory analysisPatients diagnosed as having abnormal hemoglobin like hemoglobin S and thalassemia in a bedouin village |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients diagnosed with abnormal hemoglobin in the bedouin arab village
Key inclusion criteria (1 listed)
- All the patients that were diagnosed as having sickle cell disease in the specific village and all the population screened for hemoglobinopathies in the same location
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Medical history and basic laboratory analysisMedical history and basic laboratory analysis | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2009.
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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
luci Zalman, Phd study chair
Hematology Laboratory - HaEmek Medical Center
Tania Flaishman, Student principal investigator
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 Sickle Cell Disease, 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 0 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: finished, as of the sponsor's last update on 4 Sep 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 4 Sep 2009.