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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name