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Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01443312
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel

Tracking Information
First Submitted Date September 27, 2011
First Posted Date September 29, 2011
Last Update Posted Date November 1, 2019
Study Start Date October 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2013)
The characteristics of patients with thalassemia intermedia [ Time Frame: One year ]
Observational study that analyzed the characteristics of thalassemia intermedia patients
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia
Official Title Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia
Brief Summary The definition of Thalassemia Intermedia is not generally accepted and the specific clinical and laboratory characteristics varies between patients. Some patients are blood transfusion dependent and others are occasionally transfused. Also the mutations in the beta globin gene are diverse. Another mutations including mutations in the alfa globin gene and in the xmn1 gene can affect the clinical course of this disease. The purpose of this study is to summarize the characteristics of patients with Thalassemia Intermedia treated at the Pediatric Hematology Unit at the HaEmek Medical Center in Israel
Detailed Description

The characteristics that will be recorded from the medical files include: demographic data, included gender and ethnic origin, family history, age at diagnosis, number and frequency of blood transfusions including age of first transfusion and physical examination findings.

The laboratory data included iron metabolism parameters, mutation in the alfa and beta gene and the presence of the xmn1 polymorphism.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA samples will be obtained to analyze the beta and alfa globin genes and the xmn1 polymorphism.
Sampling Method Non-Probability Sample
Study Population Patients with beta Thalassemia Intermedia.
Condition Thalassemia
Intervention Genetic: Laboratory analysis.
The blood transfusions given to the patients are in accord to physician decision and not related to the study
Study Groups/Cohorts Thalassemia Intermedia Patients
Patients with Beta Thalassemia Intermedia treated at the Pediatric Hematology Unit. The characterization of Thalassemia Intermedia was based on age at diagnosis (Older than 2 ys) and / or clinical characteristics that are milder than Thalassemia Major in patients homozygous for beta globin genes.
Intervention: Genetic: Laboratory analysis.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 30, 2015)
28
Original Estimated Enrollment
 (submitted: September 28, 2011)
30
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

-All patients treated at the Pediatric Hematology Unit

Exclusion Criteria:

  • Not enough medical records.
  • Patients who refuse to give consent to perform genetic studies will be included in the study but only the retrospective clinical data will be recorded.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 40 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01443312
Other Study ID Numbers 0047-10-EMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Koren Ariel, HaEmek Medical Center, Israel
Study Sponsor HaEmek Medical Center, Israel
Collaborators Not Provided
Investigators
Principal Investigator: Ariel Koren, MD Ha'Emek Medical Center, Afula, Israel
PRS Account HaEmek Medical Center, Israel
Verification Date October 2019