UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004605
Receipt number 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 17:20:49

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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 or person

Institute

Department of Pediatrics, Graduate School of Medicine, Gifu University

Institute

Department

Personal name



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

Value
https://center6.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