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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017659
Receipt No. R000020469
Scientific Title microbiome analysis in patients with diffuse pulmonary disease
Date of disclosure of the study information 2015/05/25
Last modified on 2020/05/29

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Basic information
Public title microbiome analysis in patients with diffuse pulmonary disease
Acronym microbiome analysis in patients with diffuse pulmonary disease
Scientific Title microbiome analysis in patients with diffuse pulmonary disease
Scientific Title:Acronym microbiome analysis in patients with diffuse pulmonary disease
Region
Japan

Condition
Condition patients with diffuse pulmonary disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 analysis of microbiome in patients with diffuse pulmonary disease
Basic objectives2 Others
Basic objectives -Others epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes detection of microbiome in patients with diffuse pulmonary disease
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with diffuse pulmonary disease/
Patients who gave written informed consent.
Key exclusion criteria Patients who could not underwent examination.
Patients who did not give written informed consent.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Osamu
Middle name
Last name Taguchi
Organization Mie University Graduate School of Medicine
Division name Dep. of Pulmonary and Critical Care Medicine
Zip code 5148507
Address 2-174,Edobashi,Tsu,Mie,514-8507,Japan
TEL 059-232-1111
Email taguchio@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Tetsu
Middle name
Last name Kobayashi
Organization Mie University Graduate School of Medicine
Division name Dep. of Pulmonary and Critical Care Medicine
Zip code 5148507
Address 2-174,Edobashi,Tsu,Mie,514-8507,Japan
TEL 059-232-1111
Homepage URL
Email kobayashitetsu@hotmail.com

Sponsor
Institute Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization mie university
Address 2-174, edobashi, Tsu, Mie, Japan
Tel 0592321111
Email s-kikaku1@mo.medic.mie-u.ac.jp

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 05 Month 25 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020469
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020469
Number of participants that the trial has enrolled 3
Results
analysis of microbiome
Results date posted
2020 Year 05 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with diffuse lung disease
Participant flow
using sample of balf
Adverse events
none
Outcome measures
analysis of microbiome
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 03 Month 07 Day
Date of IRB
2014 Year 03 Month 07 Day
Anticipated trial start date
2015 Year 05 Month 25 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective random sampling

Management information
Registered date
2015 Year 05 Month 24 Day
Last modified on
2020 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020469

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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