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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027235
Receipt No. R000031203
Scientific Title Study on the effect of COPD on tumor-microenvironment of the lung
Date of disclosure of the study information 2017/05/03
Last modified on 2019/05/06

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Basic information
Public title Study on the effect of COPD on tumor-microenvironment of the lung
Acronym The effect of COPD on tumor-microenvironment of the lung
Scientific Title Study on the effect of COPD on tumor-microenvironment of the lung
Scientific Title:Acronym The effect of COPD on tumor-microenvironment of the lung
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to explore the relationship between COPD and CAF in the tumor-microenvironment exploratory.
Basic objectives2 Others
Basic objectives -Others Evaluation of relationship (retrospective)
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between CAF distribution in tumor-microenvironment and COPD
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 admitted to respiratory surgery at Shiga University of Medical Science Hospital during the period from 1 January 2014 to 31 December 2016, diagnosed as non-small cell lung cancer and underwent surgical resection.
Key exclusion criteria The patients who refused to participate in this research.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yasuhiko
Middle name
Last name Ohshio
Organization Shiga University of Medical Science
Division name Department of Chest Surgery
Zip code 5202192
Address Seta Tsukinowa, Otsu ,Shiga ,JAPAN
TEL 077-548-2244
Email yasuhiko@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Yasuhiko
Middle name
Last name Ohshio
Organization Shiga University of Medical Science
Division name Department of Chest Surgery
Zip code 5202192
Address Seta Tsukinowa, Otsu ,Shiga ,JAPAN
TEL 077-548-2244
Homepage URL
Email yasuhiko@belle.shiga-med.ac.jp

Sponsor
Institute Seta Tsukinowa, Otsu ,Shiga ,JAPAN
Institute
Department

Funding Source
Organization Seta Tsukinowa, Otsu ,Shiga ,JAPAN
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shiga University of Medical Science
Address Seta Tsukinowa, Otsu ,Shiga ,JAPAN
Tel 077-548-2244
Email yasuhiko@belle.shiga-med.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
2017 Year 05 Month 03 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 45
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
2016 Year 04 Month 20 Day
Date of IRB
2017 Year 04 Month 20 Day
Anticipated trial start date
2017 Year 04 Month 20 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 05 Month 03 Day
Last modified on
2019 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031203

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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