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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031612
Receipt No. R000036085
Scientific Title Investigation of the prognostic factor of the interstitial pneumonia by using the analysis of intrapulmonary microbiome.
Date of disclosure of the study information 2018/05/01
Last modified on 2018/09/05

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Basic information
Public title Investigation of the prognostic factor of the interstitial pneumonia by using the analysis of intrapulmonary microbiome.
Acronym Prognostic factor of the interstitial pneumonia based on microbiome analysis.
Scientific Title Investigation of the prognostic factor of the interstitial pneumonia by using the analysis of intrapulmonary microbiome.
Scientific Title:Acronym Prognostic factor of the interstitial pneumonia based on microbiome analysis.
Region
Japan

Condition
Condition interstitial pneumonia
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate intrapulmonary microbiome in the interstitial pneumonia. Also, by comparison with the clinical course of each case, we establish a prognostic factor method using a characteristic of the microbiome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intrapulmonary microbiome at diagnosis, and reduction ratio of the forced vital capacity during three years.
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
99 years-old >
Gender Male and Female
Key inclusion criteria Patients with interstitial pneumonia
Key exclusion criteria The patients who cannot undergo bronchoalveolar lavage.
The patients with the serious respiratory disorder.
A pregnant woman and the patients who may be pregnant.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ishimoto
Organization Nagasaki university hospital
Division name Respiratory medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki city
TEL 095-819-7273
Email h-ishimoto@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Ishimoto
Organization Nagasaki university hospital
Division name Respiratory medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki city
TEL 095-819-7273
Homepage URL
Email h-ishimoto@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki university hospital
Institute
Department

Funding Source
Organization Nagasaki university hospital
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
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
2018 Year 05 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 05 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 We examine association of intrapulmonary microbiome at diagnosis and reduction ratio of the forced vital capacity during three years in patients with interstitial pneumonia.

Management information
Registered date
2018 Year 03 Month 06 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036085

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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