Detection Of β-thalassemia Carriers In Assiut

NCT03822585 | Unknown

• 1 other identifier: Thalassemia Carriers
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Beta-Thalassemia

Keywords

HbA2, HPLC

Outcome Measures

Primary Outcomes (1)

• detection of thalassemia carriers in children with microcytic hypochromic anemia

  accurate detection of prevalence rate of thalassemia carriers among relatives of β-thalassemia

  2 years

Study Arms (1)

Close Relatives Of β-thalassemia

OTHER

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

Interventions

CBC, Iron Study, Serum Ferrittin, HPLC,Genitic Study DIAGNOSTIC_TEST

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%.

Close Relatives Of β-thalassemia

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Normocytic Normochromic Anemia
• Iron Deficiency Anemia

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Mohammed HM Ghazally, PROF

  Assiut University Child Hospital

  STUDY DIRECTOR

Central Study Contacts

Shimaa MR Abdelhakeem, MD

CONTACT

+201025713965-+96567773851; shimaaradi2007@yahoo.com

Ahmed MR Abdelhakeem

CONTACT

+201003127990; hmradi30@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Close Relatives Of β-Thalassemia Will Do Laboratory Tests

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: January 30, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2021
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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