UMIN-CTR Clinical Trial

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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