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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006557
Receipt No. R000007770
Scientific Title Evaluating biomarkers for idiopathic interstitial pneumonia.
Date of disclosure of the study information 2011/10/20
Last modified on 2016/04/17

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Basic information
Public title Evaluating biomarkers for idiopathic interstitial pneumonia.
Acronym New biomarkers for idiopathic interstitial pneumonia.
Scientific Title Evaluating biomarkers for idiopathic interstitial pneumonia.
Scientific Title:Acronym New biomarkers for idiopathic interstitial pneumonia.
Region
Japan

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

Objectives
Narrative objectives1 Evaluating lipid mediators and their producing enzymes in serum and BAL fluid from patients with interstitial pneumonia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in concentration according to disease progress.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are diagnosed as interstitial pneumonia.
Key exclusion criteria Patients who disagree with involving in this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi KUBO
Organization Tohoku University Graduate School of Medicine
Division name Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address 2-1 Seiryoumachi, Aobaku Sendai JAPAN
TEL 022-717-7174
Email hkubo@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi KUBO
Organization Tohoku University Graduate School of Medicine
Division name Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address 2-1 Seiryoumachi, Aobaku Sendai JAPAN
TEL 022-717-7184
Homepage URL
Email hkubo@med.tohoku.ac.jp

Sponsor
Institute Department of Advanced Preventive Medicine for Infectious Disease, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization National Institute of Biomedical Innovation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japanese Red-Cross Ishinomaki Hospital
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
2011 Year 10 Month 20 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 Completed
Date of protocol fixation
2011 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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 Sampling is made only from patients who are diagnosed as interstitial pneumonia.

Management information
Registered date
2011 Year 10 Month 17 Day
Last modified on
2016 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007770

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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