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Detection Of β-thalassemia Carriers In Assiut

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03822585
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Shimaa Mohammed Radi Abdelhakeem, Assiut University

Brief Summary:

Thalassemia is different in kids with microcytic hypochromic anemia than general population because there is a confusion between symptoms of thalassemia and iron deficiency anemia in kids and both of them differ in management and prognosis. otherwise the most commonest causes of microcytic hypochromic anemia in kids are iron deficiency anemia and thalassemia and both of them are more common in kids than in general population.

Thalassemia is different in Egypt than anywhere in the world because there is no accurate estimation of incidence and prevalence of such dangerous disease in Egypt inspite of many cases attending thalassemia center (hundreds) and this disease is autosomal recessive and its incidence can be minimized by detection of carrier cases by gene study hopping that to be done as a routine premarital investigation.


Condition or disease Intervention/treatment Phase
Beta-Thalassemia Diagnostic Test: CBC, Iron Study, Serum Ferrittin, HPLC,Genitic Study Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Close Relatives Of β-Thalassemia Will Do Laboratory Tests
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Detection of β-thalassemia Carriers Among Close Relatives of β-thalassemia Children Attending Assiut University Children Hospital
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Close Relatives Of β-thalassemia
Laboratory diagnostic tests as (CBC, Iron Study, Serum Ferritin, HPLC, Genetic study) will be done to Brothers, Sisters & Cousins of β-thalassemia Children With Microcytic Hypochromic Anemia Attending Assiut University Child Hospital
Diagnostic Test: CBC, Iron Study, Serum Ferrittin, HPLC,Genitic Study

high performance liquid chromatography (HPLC) has become the preferred technique, as it can detect most of the clinically significant variants. polymerase chain reaction (PCR)-based procedures detect Commonly occurring mutations of the HBB gene .

If targeted mutation analysis fails to detect the mutation, scanning or sequence analysis can be used. Sensitivity of both mutation scanning and sequence analysis is 99%.





Primary Outcome Measures :
  1. detection of thalassemia carriers in children with microcytic hypochromic anemia [ Time Frame: 2 years ]
    accurate detection of prevalence rate of thalassemia carriers among relatives of β-thalassemia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Close Relatives Of B-Thalassemia Carriers With Microcytic Hypochromic Anemia

Exclusion Criteria:

  • Normocytic Normochromic Anemia
  • Iron Deficiency Anemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822585


Contacts
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Contact: Shimaa MR Abdelhakeem, MD +201025713965-+96567773851 shimaaradi2007@yahoo.com
Contact: Ahmed MR Abdelhakeem +201003127990 hmradi30@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Mohammed HM Ghazally, PROF Assiut University Child Hospital

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Responsible Party: Shimaa Mohammed Radi Abdelhakeem, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03822585    
Other Study ID Numbers: Thalassemia Carriers
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to make IPD and related data dictionaries available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: data will become available in January 2021 for unlimited years
Access Criteria: Through finding the research in the site of ClinicalTrials.gov
URL: http://shimaaradi2007@yahoo.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shimaa Mohammed Radi Abdelhakeem, Assiut University:
HbA2, HPLC
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn