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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | patients with diffuse pulmonary disease | |
Classification by specialty |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with diffuse pulmonary disease/
Patients who gave written informed consent. |
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Key exclusion criteria | Patients who could not underwent examination.
Patients who did not give written informed consent. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |