UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017659 |
|---|---|
| Receipt number | 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 18:26:07 |
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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
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
kobayashitetsu@hotmail.com
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
