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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002255
Receipt No. R000002760
Scientific Title assessment of immune system in child food after thymus extirpation at cardiac operation
Date of disclosure of the study information 2009/07/27
Last modified on 2013/01/27

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Basic information
Public title assessment of immune system in child food after thymus extirpation at cardiac operation
Acronym AISCF
Scientific Title assessment of immune system in child food after thymus extirpation at cardiac operation
Scientific Title:Acronym AISCF
Region
Japan

Condition
Condition the patient with cardiopulmonary bupass in Infant
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate about clinical effect of immune system after thymus extirpation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes blood test
Key secondary outcomes infectious disease, death

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
0 months-old <=
Age-upper limit
6 months-old >
Gender Male and Female
Key inclusion criteria infant
Key exclusion criteria the patients older than 6 month old
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yousuke Takahama
Organization the University of TOKUSHIMA Graduate School
Division name institute for genome research
Zip code
Address 3-18-15 Kuramoto-chou, TOKUSHIMA, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu KUROBE
Organization the universuty of TOKUSHIMA Graduate of School
Division name Department of Cardiovascular Surgery
Zip code
Address 3-18-15 Kuramoto-chou, TOKUSHIMA, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute TOKUSHIMA university
Institute
Department

Funding Source
Organization the univ. of TOKUSHIMA
Organization
Division
Category of Funding Organization Other
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
2009 Year 07 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2004 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information blood test, seeing at outpatients' clinic

Management information
Registered date
2009 Year 07 Month 27 Day
Last modified on
2013 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002760

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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