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

• Sponsor: HaEmek Medical Center, Israel (Other)
• Overall Status: Completed
• CT.gov ID: NCT01443312
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Duration (Months): 38
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Thalassemia	Genetic: Laboratory analysis.

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 Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.	Genetic: Laboratory analysis.; The blood transfusions given to the patients are in accord to physician decision and not related to the study

Outcome Measures

Primary Outcome Measures

1. The characteristics of patients with thalassemia intermedia [One year]

   Observational study that analyzed the characteristics of thalassemia intermedia patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Hematology Unit - Ha'Emek Medical Center	Afula		Israel	18101

Sponsors and Collaborators

• HaEmek Medical Center, Israel

Investigators

• Principal Investigator: Ariel Koren, MD, Ha'Emek Medical Center, Afula, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel
• ClinicalTrials.gov Identifier: NCT01443312
• Other Study ID Numbers: 0047-10-EMC
• First Posted: Sep 29, 2011
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel: Beta globin gene; Alfa globin gene; xmn1 polymorphism
• Additional relevant MeSH terms: Thalassemia; beta-Thalassemia

Study Results

No Results Posted as of Nov 1, 2019