UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory research of COPD clinical stratification by Radwisp.-prospective observational study-
Acronym	Exploratory research of COPD clinical stratification by Radwisp.
Scientific Title	Exploratory research of COPD clinical stratification by Radwisp.-prospective observational study-
Scientific Title:Acronym	Exploratory research of COPD clinical stratification by Radwisp.
Region	Japan

Condition
Condition	COPD:Chronic Obstructive Pulmonary Disease
Classification by specialty	Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verify agreement rates for diagnosed COPD staging. Evaluation results of COPD classification evaluation with Radwisp (X-Ray image fluoroscopic analysis software) and evaluation results with treatment guidelines (5th Edition).
Basic objectives2	Others
Basic objectives -Others	Verification of concordance rates of COPD staging.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Confirmation of concordance rate of COPD staging. Diagnosis based on COPD staging judgment results and guidelines for COPD diagnosis and treatment (5th edition) by Radwisp
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.The established patient COPD staging is based on the guidelines for COPD diagnosis and treatment (5th edition) 2.Patients scheduled for chest x-ray. 3.At the time of patient consent acquisition 20 years or older 4.Patients who obtained written consent from the person to participate in this study.
Key exclusion criteria	None of the exclusion criteria
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hirohisa Middle name Last name Yoshizawa
Organization	Niigata Medical Center
Division name	Respiratory medicine
Zip code	950-2022
Address	3-27-11,Kobari,Niigata shi,Nishi ku,Niigata Ken
TEL	025-232-0111
Email	nnys@icloud.com

Public contact
Name of contact person	1st name Yasuhiko Middle name Last name Yoshida
Organization	Nouvelle Place Inc.
Division name	Research Management Office
Zip code	105-0001
Address	Toranomon 33 Mori Building,
TEL	03-6680-2525
Homepage URL
Email	ya-yoshida@m3.com

Sponsor
Institute	Mediotto. Inc
Institute
Department

Funding Source
Organization	Mediotto.Inc
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Koseiren Hospital Central Institutional Review Board
Address	2-5-5 Yoyogi, Shibya-ku, Tokyo
Tel	03-3370-1730
Email	j-nishiyama@bunkaren.or.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	新潟県厚生農業協同組合連合会 新潟医療センター（新潟県） Niigata Medical Center (Niigata Prefecture)

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 10 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 18 Day
Date of IRB	2019 Year 08 Month 22 Day
Anticipated trial start date	2019 Year 09 Month 03 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not application.

Management information
Registered date	2019 Year 09 Month 10 Day
Last modified on	2020 Year 09 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043293