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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002727
Receipt No. R000002127
Scientific Title Utility of Antigen Detecting Tests of Serum and BALF in Diagnosing Respiratory Infectious Diseases
Date of disclosure of the study information 2009/11/09
Last modified on 2009/11/09

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Basic information
Public title Utility of Antigen Detecting Tests of Serum and BALF in Diagnosing Respiratory Infectious Diseases
Acronym Antigen Detecting Tests of Serum and BALF for Diagnosing Respiratory Infectious Diseases
Scientific Title Utility of Antigen Detecting Tests of Serum and BALF in Diagnosing Respiratory Infectious Diseases
Scientific Title:Acronym Antigen Detecting Tests of Serum and BALF for Diagnosing Respiratory Infectious Diseases
Region
Japan

Condition
Condition Respiratory Infectious Diseases
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of Antigen Detecting Tests of serum and BALF in Respiratory Infectious Diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes corresponding rate of the result of antigen and culture tests
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Antigen Detecting Test
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 Patients with respiratory diseases
Key exclusion criteria Patients without respiratory diseases
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kohno
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Molecular Microbiology and Immunology
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Izumikawa
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Molecular Microbiology and Immunology
Zip code
Address
TEL
Homepage URL
Email koizumik@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Nagasaki University Graduate School of Biomedical Sciences
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 11 Month 09 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 Open public recruiting
Date of protocol fixation
2009 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 09 Day
Last modified on
2009 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002127

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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