UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018950 |
|---|---|
| Receipt number | R000021923 |
| Scientific Title | Characterization of Circulating CD4+CD8+Double Positive and CD4-CD8- Double Negative T-Lymphocyte in children with beta-Thalassemia major |
| Date of disclosure of the study information | 2015/09/12 |
| Last modified on | 2017/02/15 05:31:50 |
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Basic information
Public title
Characterization of Circulating CD4+CD8+Double Positive and CD4-CD8- Double Negative T-Lymphocyte in children with beta-Thalassemia major
Acronym
Unconventional T-lymphocyte subsets in beta-Thalassemia.
Scientific Title
Characterization of Circulating CD4+CD8+Double Positive and CD4-CD8- Double Negative T-Lymphocyte in children with beta-Thalassemia major
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Khaled Saad |
Organization
Associate professor of Pediatrics, Faculty of medicine,
University of Assiut, Assiut 71516, Egypt.
Division name
Pediatric Department
Zip code
Address
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL
+81-0201006080182
khaled.ali@med.au.edu.eg
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asmaa M. Zahran |
Organization
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name
Clinical pathology department
Zip code
Address
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL
20882368373
Homepage URL
asmaa.zahran@yahoo.com
Sponsor or person
Institute
Faculty of medicine,
University of Assiut, Assiut 71516, Egypt.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021923
