Sickle Cell AnemiaNCT01905787
Sickle Cell Anemia - A Comparative Study Between Three Ethnical Communities, a Multicenter Study
An observational study of Sickle Cell Anemia and Sickle Cell β+ or β0 Thalassemia, run by HaEmek Medical Center, Israel at 4 sites in 2 countries.
Trial summary
The purpose of this study is to take advance of the presence of two different cohorts of SCA patients in one country, the first group included SCA patients from Bedouin Arab origin that lives in Israel for more than one century and originally comes from African countries or Saudi Arabia, those patients lives in north… Read more about this study
- Who is it for?
- Ages 1 year to 40 years
- Conditions the study is for
- Sickle Cell Anemia, Sickle Cell β+ or β0 Thalassemia
- How many people
- 300 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2012to 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 1 year to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Group 1 - Emek group - (EMC): 100 patients will be included in the study, including Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+ patients will be included). Group 2 - Dana group - (DMC): 50 patients will be included in the study. Group 3 - Schneider group - (ShMC): 50 patients will be included in the study. Group 4 - Detroit group - (WYUMC): 100 patients will be included in the study, Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+) will be included).
Who may be able to join
- All patients followed up in the centers that participate in the study.
- Pregnancy will not be considered as exclusion criteria.
Who cannot join
- Patients with SC and SD disease will not be included.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Israel3 sites
Pediatric Hematology Unit HaEmek Medical Center
Afula, 18101
Pediatric Hematology Unit - Schneider Children's Hospital - Beilinson Medical Center
Petah Tikva
Pediatric Hematology Unit - Dana Children's Hospital - Ichilov Medical Center
Tel Aviv
United States1 site
Children's Hospital of Michigan, Detroit Medical Center - Wayne State University
Detroit, Michigan
About this study
Official title: Sickle Cell Anemia - A Comparative Study Between Three Ethnical Communities, a Multicenter Study. Clinical and Genetic Characteristics of Sickle Cell Anemia (SCA) Patients in Three Different Communities.
The purpose of this study is to take advance of the presence of two different cohorts of SCA patients in one country, the first group included SCA patients from Bedouin Arab origin that lives in Israel for more than one century and originally comes from African countries or Saudi Arabia, those patients lives in north east Israel and are treated at the Hematology Unit of the Emek Medical Center, the second group are SCA patients from African origin that come to Israel in the last decades and belong to original African population, this group receive treatment at the Pediatric Hematology Unit, Dana Children's Hospital, Ichilov Medical Center. A third group is a cohort of SCA patients treated at Schneider Children's Hospital Hematology Unit. Those patients belong also to the Israel Arab population and patients from a village that African Muslims live for many years. The characteristics of the three groups will be compared to the characteristics of a fourth group, a cohort of Afro-American SCA patients that are followed up and treated at the Pediatric Hematology Unit, Detroit Children's Medical Center, Detroit, Michigan, USA.
Read the detailed description
Group 1 - Emek group - (EMC): 100 patients will be included in the study, including Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+ patients will be included).
Group 2 - Dana group - (DMC): 50 patients will be included in the study. Group 3 - Schneider group - (ShMC): 50 patients will be included in the study. Group 4 - Detroit group - (WYUMC): 100 patients will be included in the study, Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+) will be included).
Patients with Sickle cell hemoglobin C (SC) and Sickle cell hemoglobin D (SD) disease will not be included as part of the study analysis due to the small numbers of patients expected, but the investigators are encouraged to report the data of those patients for further analysis.
Age: No age limits, patients can be included since diagnosis till age 40 since teenagers and young adults are often treated at pediatric hematology units.
Gender: Males and Females will be included in the study. Pregnant patients: Pregnancy will not be considered as exclusion criteria. Data about pregnancy under Hydroxyurea treatment both in females and in males should be included, including malformations in the offspring. It needs to be emphasized that the recommendation to the patients in both sexes is to stop Hydroxyurea treatment at last three months before conception.
Data collection: Data will be collected from the medical files. Demographic and family history and laboratory findings at diagnosis will be included.
Genetic mutations of the β globin gene in patients with Sickle Cell β thalassemia will be included if previously analyzed and recorded in medical files. Also α globin mutations and SCA haplotypes will be included if they were previously analyzed and are part of the data already present in the medical files.
Further genetic analysis including β and α globin mutations, haplotypes and xmn1 polymorphism will be included in an extension study but those analysis are not an integral part of this initial study unless they were performed before this present study.
Clinical complaints from the last 10 years will be summarized. Iron chelation and Hydroxyurea treatment given in the last 10 years will be summarized.
Complications that were diagnosed at any age will also be recorded.
Exclusion criteria:
- Patients without sufficient data at the medical files due to lack of regular follow up will be excluded.
- Patients that give explicit refuse in participation.
Inclusion criteria:
- All the patients currently treated and followed up at the centers in Israel will be included.
- A similar number of patients at same age range and same diagnosis will be included from the whole cohort at Detroit MC. Since at Detroit MC a significant larger number of patients, the criteria for patient's selection at this center will be a cohort matched for gender and age to the Israel patients.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 - Dana group | 50 patients will be included in the study. | |
| Group 3 - Schneider group | 50 patients will be included in the study | |
| Group 4 - Detroit group | 100 patients will be included in the study, Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+) will be included). | |
| Group 1 - Emek group | 100 patients will be included in the study, including Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+ patients will be included). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical comparative study between four different Sickle Cell Populations
Clinical events during the observational period including crises, blood transfusions requirements and hospitalizations.
Measured: 5 years
Secondary outcomes (1)
Clinical severity and laboratory results related to the Sickle Cell disease
Laboratory analysis results (Blood count, Hgb F and tests related to hemolysis) will be compared between the different groups
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJan 2012
- 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 Sickle Cell AnemiaStudies 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
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905787
- Sponsor's protocol ID
- 0128-11-EMC
- Status last verified
- Oct 2019
- First submitted
- 18 Feb 2013
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Anemia - A Comparative Study Between Three Ethnical Communities, a Multicenter Study. Clinical and Genetic Characteristics of Sickle Cell Anemia (SCA) Patients in Three Different Communities.
- ClinicalTrials.gov ID
- NCT01905787
- Acronym / sponsor ID
- 0128-11-EMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Jul 2013 (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.
The purpose of this study is to take advance of the presence of two different cohorts of SCA patients in one country, the first group included SCA patients from Bedouin Arab origin that lives in Israel for more than one century and originally comes from African countries or Saudi Arabia, those patients lives in north east Israel and are treated at the Hematology Unit of the Emek Medical Center, the second group are SCA patients from African origin that come to Israel in the last decades and belong to original African population, this group receive treatment at the Pediatric Hematology Unit, Dana Children's Hospital, Ichilov Medical Center. A third group is a cohort of SCA patients treated at Schneider Children's Hospital Hematology Unit. Those patients belong also to the Israel Arab population and patients from a village that African Muslims live for many years. The characteristics of the three groups will be compared to the characteristics of a fourth group, a cohort of Afro-American SCA patients that are followed up and treated at the Pediatric Hematology Unit, Detroit Children's Medical Center, Detroit, Michigan, USA.
Detailed description
Group 1 - Emek group - (EMC): 100 patients will be included in the study, including Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+ patients will be included).
Group 2 - Dana group - (DMC): 50 patients will be included in the study. Group 3 - Schneider group - (ShMC): 50 patients will be included in the study. Group 4 - Detroit group - (WYUMC): 100 patients will be included in the study, Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+) will be included).
Patients with Sickle cell hemoglobin C (SC) and Sickle cell hemoglobin D (SD) disease will not be included as part of the study analysis due to the small numbers of patients expected, but the investigators are encouraged to report the data of those patients for further analysis.
Age: No age limits, patients can be included since diagnosis till age 40 since teenagers and young adults are often treated at pediatric hematology units.
Gender: Males and Females will be included in the study. Pregnant patients: Pregnancy will not be considered as exclusion criteria. Data about pregnancy under Hydroxyurea treatment both in females and in males should be included, including malformations in the offspring. It needs to be emphasized that the recommendation to the patients in both sexes is to stop Hydroxyurea treatment at last three months before conception.
Data collection: Data will be collected from the medical files. Demographic and family history and laboratory findings at diagnosis will be included.
Genetic mutations of the β globin gene in patients with Sickle Cell β thalassemia will be included if previously analyzed and recorded in medical files. Also α globin mutations and SCA haplotypes will be included if they were previously analyzed and are part of the data already present in the medical files.
Further genetic analysis including β and α globin mutations, haplotypes and xmn1 polymorphism will be included in an extension study but those analysis are not an integral part of this initial study unless they were performed before this present study.
Clinical complaints from the last 10 years will be summarized. Iron chelation and Hydroxyurea treatment given in the last 10 years will be summarized.
Complications that were diagnosed at any age will also be recorded.
Exclusion criteria:
- Patients without sufficient data at the medical files due to lack of regular follow up will be excluded.
- Patients that give explicit refuse in participation.
Inclusion criteria:
- All the patients currently treated and followed up at the centers in Israel will be included.
- A similar number of patients at same age range and same diagnosis will be included from the whole cohort at Detroit MC. Since at Detroit MC a significant larger number of patients, the criteria for patient's selection at this center will be a cohort matched for gender and age to the Israel patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 2 - Dana group | – | –50 patients will be included in the study. |
| Group 3 - Schneider group | – | –50 patients will be included in the study |
| Group 4 - Detroit group | – | –100 patients will be included in the study, Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+) will be included). |
| Group 1 - Emek group | – | –100 patients will be included in the study, including Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+ patients will be included). |
Who may qualify
- Ages
- 1 year to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Group 1 - Emek group - (EMC): 100 patients will be included in the study, including Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+ patients will be included). Group 2 - Dana group - (DMC): 50 patients will be included in the study. Group 3 - Schneider group - (ShMC): 50 patients will be included in the study. Group 4 - Detroit group - (WYUMC): 100 patients will be included in the study, Homozygous SCA patients and Sickle Cell β Thalassemia Patients (β0 and β+) will be included).
Key inclusion criteria (2 listed)
- All patients followed up in the centers that participate in the study.
- Pregnancy will not be considered as exclusion criteria.
Key exclusion criteria (1 listed)
- Patients with SC and SD disease will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical comparative study between four different Sickle Cell Populations
Time frame: 5 years
Clinical events during the observational period including crises, blood transfusions requirements and hospitalizations.
1 secondary outcome
Clinical severity and laboratory results related to the Sickle Cell disease
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Anemia and Sickle Cell β+ or β0 Thalassemia, run by HaEmek Medical Center, Israel at 4 sites in 2 countries.
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 2 inclusion and 1 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 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, United States. 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?
Clinical comparative study between four different Sickle Cell Populations (time frame: 5 years). 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 31 Oct 2019.