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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004605
Receipt No. R000005499
Scientific Title The clinical research for innate immune deficiency syndrome
Date of disclosure of the study information 2010/12/10
Last modified on 2014/05/27

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Basic information
Public title The clinical research for innate immune deficiency syndrome
Acronym The research for innate immune deficiency
Scientific Title The clinical research for innate immune deficiency syndrome
Scientific Title:Acronym The research for innate immune deficiency
Region
Japan

Condition
Condition The innate immune deficiency syndromes
Classification by specialty
Medicine in general Infectious disease Pediatrics
Adult Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The genetic diagnosis for innate immune deficiency syndromes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The genetic diagnosis for suspected patient of the innate immune deficiency syndromes
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Gene
Interventions/Control_1 No. 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient who showed the recurrent severe infections from the childhood period.
Key exclusion criteria The patient who diagnosed the primary immune deficiency syndromes except for innate immune disorders, or acquired immune deficiency syndromes
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenori Ohnishi
Organization Graduate School of Medicine, Gifu University
Division name Pediatrics
Zip code
Address Yanagido 1-1, Gifu
TEL +81-058-230-6386
Email ohnishih@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Ohnishi
Organization Graduate School of Medicine, Gifu University
Division name Pediatrics
Zip code
Address Yanagido 1-1, Gifu
TEL +81-058-230-6386
Homepage URL
Email ohnishih@gifu-u.ac.jp

Sponsor
Institute Department of Pediatrics, Graduate School of Medicine, Gifu University
Institute
Department

Funding Source
Organization Health and Labour Science Research Grants for Research on Intractable Disease from the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
2010 Year 12 Month 10 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 Preinitiation
Date of protocol fixation
2010 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 12 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
2010 Year 11 Month 23 Day
Last modified on
2014 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005499

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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