Sickle Cell Anemia in an Arab Bedouin Village in the Nort... | NCT00481039

Studies
Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel

NCT00481039

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Sep 4, 2009Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Sickle Cell Disease

Interventions

Medical history and basic laboratory analysis

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

May 31, 2007

First Submission Date that Met QC Criteria

May 31, 2007

First Posted Date

Jun 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2009

Last Update Posted Date

Sep 4, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients diagnosed as having abnormal hemoglobin like hemoglobin S and thalassemia in a bedouin village	Procedure: Medical history and basic laboratory analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical history and basic laboratory analysis	Procedure	Medical history and basic laboratory analysis	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All the patients diagnosed with abnormal hemoglobin in the bedouin arab village

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ariel Koren, MD	Pediatric Hematology Unit, Ha'Emek Medical Center	Study Director
luci Zalman, Phd	Hematology Laboratory - HaEmek Medical Center	Study Chair
Tania Flaishman, Student	Pediatric Dpt B - Ha'Emek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Hematology Unit - HaEmek Medical Center		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055991	Health Records, Personal

Ancestor Terms

ID	Term
D008499	Medical Records
D011996	Records
D003625	Data Collection
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided