UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Exploration for the Association of Chronic Obstructive Lung Disease/Emphysema with Incidence of Chronic Respiratory Diseases
Title of the study (Brief title)	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	Yoshinori Hasegawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	65 Tsurumai, SHowa-ku, Nagoya
TEL	052-741-2111
Email	hashinao@med.nagoya-u.ac.jp

Public contact
Name of contact person	Naozumi Hashimoto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Respiratory Medicine
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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012485