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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010677
Receipt No. R000012485
Scientific Title Prospective Exploration for the Association of Chronic Obstructive Lung Disease/Emphysema with Incidence of Chronic Respiratory Diseases
Date of disclosure of the study information 2013/07/01
Last modified on 2018/05/14

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Basic information
Public title Prospective Exploration for the Association of Chronic Obstructive Lung Disease/Emphysema with Incidence of Chronic Respiratory Diseases
Acronym PEACE study
Scientific Title Prospective Exploration for the Association of Chronic Obstructive Lung Disease/Emphysema with Incidence of Chronic Respiratory Diseases
Scientific Title:Acronym PEACE study
Region
Japan

Condition
Condition Respiratory Diseases
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate incidence rate of COPD/emphysema in the patients under going bronchoscopy
Basic objectives2 Others
Basic objectives -Others To determine the importance of tissue microenvironmental factors in the pathogenesisi of respiratory meidicines
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes incidence rate of COPD/emphysema
Key secondary outcomes importance of tissue microenvironment factors in the pathogenesis of respiratory medicine

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 1. the patients undergoing bronchoscopy
2. the patients with COPD/emphysema or idiopathic interstitial pneumonia in outclinics
3. the patients defined as control
Key exclusion criteria 1. patients ineligible to undertake bronchoscopy
2. acute infections, heart failure, and pneumothorax, hemoptisis, others
3. the patients not agreeable for the study
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Hasegawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 65 Tsurumai, SHowa-ku, Nagoya
TEL 052-741-2111
Email hashinao@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naozumi Hashimoto
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 65 Tsurumai, SHowa-ku, Nagoya
TEL 052-741-2111
Homepage URL
Email hashinao@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Department of Respiratory Medicine
Institute
Department

Funding Source
Organization donation money for research
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 01 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 Terminated
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 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 Incidence rate of COPD/Emphysema in the patients undergoing bronchoscopy

Management information
Registered date
2013 Year 05 Month 09 Day
Last modified on
2018 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012485

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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