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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006692
Receipt No. R000007911
Scientific Title Analysis of susceptibility moleculde for idiopahtic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Date of disclosure of the study information 2011/11/15
Last modified on 2017/11/13

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Basic information
Public title Analysis of susceptibility moleculde for idiopahtic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Acronym Gene expression analysis of pulmonary fibrosis and emphysema
Scientific Title Analysis of susceptibility moleculde for idiopahtic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Scientific Title:Acronym Gene expression analysis of pulmonary fibrosis and emphysema
Region
Japan

Condition
Condition idiopatic pulmonary fibrosis
chronic obstructive lung disease
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the molecules relating to the development of pulmonary fibrosis and emphysema by accomplishing comprehensive gene expression analysis of fibrotic and emphysematous lung tissue.
Basic objectives2 Others
Basic objectives -Others Lung tissue without lung cancer obtained by surgical resection of lung cancer will be used. Lung tissue from patients with pulmonary fibrosis, emphysema and without these changes will be afforded to comprehensive gene expression analysis. Difference in gene expression will be analyzed to find out important molecules for pulmonary fibrosis and emphysema.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Difference in gene expression between the lung tissue from the patient with pulmonary fibrosis, emphysema and without these.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria In the case who recieved surgical resection of lung cancer, who have pumonary fibrosis or emphysema or normal lung
Key exclusion criteria The cases with lung disases other than pumonary fibrosis and emphysema
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Munakata
Organization Fukusima Medical University
Division name Department of Pulmonary Medicine
Zip code
Address Hikarigaoka-1, Fukusima City
TEL 024-547-1360
Email munakata@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Munakata
Organization Fukusima Medical University
Division name Department of Pulmonary Medicine
Zip code
Address Hikarigaoka-1, Fukusima City
TEL 024-547-1360
Homepage URL
Email munakata@fmu.ac.jp

Sponsor
Institute Fukusima Medical University, School of Medicine
Institute
Department

Funding Source
Organization Fukushima Medical University
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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
2011 Year 11 Month 15 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 No longer recruiting
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
2014 Year 01 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2015 Year 05 Month 31 Day

Other
Other related information Retrospective, case-control study to eluciddate characteristically expressed molelules for pulmonary fibrosis and emphysema

Management information
Registered date
2011 Year 11 Month 08 Day
Last modified on
2017 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007911

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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