ThalassemiaNCT00735488
Sickle Cell Anemia Screening and Prevention in Northern Israel
An observational study of Thalassemia and Sickle Cell Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Since 1987, a screening for β Thalassemia in pregnant women is carried on in northern Israel, and from 1999 all the samples were tested also for Hgb S, Hgb C, Hgb D, Hgb O Arab and others. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thalassemia, Sickle Cell Anemia
- What is being tested?
- Observational
- How many people
- 69 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The program for prevention of hemoglobinopathies in Northern Israel, instituted since 1987, covered the northern part of Israel, including the Jezreel valley, the Nazareth area, the upper Galilee, the Hula valley and the northern part of the seashore region7. The overall population in this region is about a million inhabitants with about 50 % of Arab population, and a significant percentage of them from Bedouin origin, a population that at least partially is of African origin.
Inclusion Criteria: All pregnant women tested and their husband in those cases that the woman test revealed abnormal hemoglobin.
Exclusion Criteria: No exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit - Ha'Emek Medical Center
Afula, Afula, 18101
About this study
Official title: Summary of the Data From the Prevention Programme for Hemoglobinopathies in Northern Israel
Since 1987, a screening for β Thalassemia in pregnant women is carried on in northern Israel, and from 1999 all the samples were tested also for Hgb S, Hgb C, Hgb D, Hgb O Arab and others.
In this study, the investigators intend to summarize the results of this preventive program aiming to detect couples at risk for having offspring with Thalassemia or SCA, the compliance regard to genetic counseling and prenatal diagnosis and the incidence of new affected babies born.
- Conditions
- Thalassemia, Sickle Cell Anemia
- Being tested
- Observational
- Keywords
- Thalassemia, Sickle cell anemia, Carrier detection, Prenatal Diagnosis, Genetic counseling
- Medical subject headings
- Thalassemia, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Summary of data
| Study group | Role | What they receive |
|---|---|---|
| A | Thalassemia Minor carriers Receives: Other: Observational | |
| B | Sickle cell carriers Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of carriers detected
Measured: End of study
Secondary outcomes (1)
Couples referred for prenatal diagnosis
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Israel
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
- Investigators
- Ariel Koren, MD, Principal investigator, Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735488
- Sponsor's protocol ID
- 0011-08-EMC
- Status last verified
- Aug 2015
- First submitted
- 14 Aug 2008
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Summary of the Data From the Prevention Programme for Hemoglobinopathies in Northern Israel
- ClinicalTrials.gov ID
- NCT00735488
- Acronym / sponsor ID
- 0011-08-EMC
- Conditions
- Thalassemia, Sickle Cell Anemia
- Keywords
- Thalassemia, Sickle cell anemia, Carrier detection, Prenatal Diagnosis, Genetic counseling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Ministry of Health, Israel
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Aug 2008 (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.
Since 1987, a screening for β Thalassemia in pregnant women is carried on in northern Israel, and from 1999 all the samples were tested also for Hgb S, Hgb C, Hgb D, Hgb O Arab and others.
In this study, the investigators intend to summarize the results of this preventive program aiming to detect couples at risk for having offspring with Thalassemia or SCA, the compliance regard to genetic counseling and prenatal diagnosis and the incidence of new affected babies born.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: ObservationalThalassemia Minor carriers |
| B | – | Other: ObservationalSickle cell carriers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The program for prevention of hemoglobinopathies in Northern Israel, instituted since 1987, covered the northern part of Israel, including the Jezreel valley, the Nazareth area, the upper Galilee, the Hula valley and the northern part of the seashore region7. The overall population in this region is about a million inhabitants with about 50 % of Arab population, and a significant percentage of them from Bedouin origin, a population that at least partially is of African origin.
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 |
|---|---|---|
| ObservationalSummary of data | Other | A, B |
Primary outcome
Number of carriers detected
Time frame: End of study
1 secondary outcome
Couples referred for prenatal diagnosis
Time frame: End of study
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 1 Sep 2015.
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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 principal investigator
Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
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 Sickle Cell Anemia, 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?
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 1 Sep 2015. 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.
What does the primary outcome measure?
Number of carriers detected (time frame: End of study). 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 Sep 2015.