UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Characterization of Circulating CD4+CD8+Double Positive and CD4-CD8- Double Negative T-Lymphocyte in children with beta-Thalassemia major
Title of the study (Brief title)	Unconventional T-lymphocyte subsets in beta-Thalassemia.
Region	Africa

Condition
Condition	beta-Thalassemia major
Classification by specialty	Hematology and clinical oncology Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate the phenotypic alterations in CD4+CD8+ double positive (DP), CD4-CD8- double negative (DN) and natural killer T-lymphocyte (NKT) in BTM children in comparison to healthy controls.
Basic objectives2	Others
Basic objectives -Others	evaluate the phenotypic alterations in CD4+CD8+ double positive (DP), CD4-CD8- double negative (DN) and natural killer T-lymphocyte (NKT) in BTM children in comparison to healthy controls.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The analysis of our data showed a significant high frequencies of CD4+CD8+ (double positive) T cells, CD4-CD8- (double negative) T cells and natural killer T cells in the peripheral blood of both BTM groups (splenectomized and non-splenectomized) as compared to healthy controls.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Our case control study included 80 children with BTM and 40 healthy children as controls. Assessment of unconventional T-lymphocyte populations was done by a sensitive three-color FACSCalibur flow cytometry.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	3 years-old <=
Age-upper limit	14 years-old >
Gender	Male and Female
Key inclusion criteria	The study included 3 groups; 40 BTM patients aged 3-8 years without splenectomy and 40 post-splenectomy BTM children aged 6-14 years. The two groups are on regular transfusion and chelation therapy, attending the Thalassemia Center, Pediatric Hematology Unit, Children Hospital Assiut University.
Key exclusion criteria	Patients with known diabetes, cardiac, renal, infectious, inflammatory or pulmonary diseases, newly diagnosed and non-transfusion dependent BTM cases were excluded from the study. Any patient had received any immunosuppressive medications e.g. steroids etc. during one month prior to enrollment were also excluded.
Target sample size	80

Research contact person
Name of lead principal investigator	Khaled Saad
Organization	Associate professor of Pediatrics, Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name	Pediatric Department
Address	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL	+81-0201006080182
Email	khaled.ali@med.au.edu.eg

Public contact
Name of contact person	Asmaa M. Zahran
Organization	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name	Clinical pathology department
Address	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL	20882368373
Homepage URL
Email	asmaa.zahran@yahoo.com

Sponsor
Institute	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Institute
Department

Funding Source
Organization	Available resources in our university
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 12 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 01 Month 01 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 09 Day
Last modified on	2017 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021923