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	We will verify the correlation between the progress of COPD determined by Radwisp (chest X-ray fluoroscopic video analysis software) and other examination methods.
Basic objectives2	Others
Basic objectives -Others	Using Radwisp (chest X-ray fluoroscopy video analysis software), perform pulmonary dynamics analysis by respiratory frequency analysis to understand pulmonary respiratory dynamics and pulmonary blood flow dynamics.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between COPD progress determined by Radwisp and spirometry test values
Key secondary outcomes	Correlation between COPD progress and CAT score as determined by Radwisp

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) Patients with COPD or suspected COPD 2) Patients who will have a chest x-ray 3) Patients who have undergone spirometry within the last 6 months and have a stable course 4) Patients over 20 years old at the time of consent 5) Patients who have given written consent 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 Masanao Middle name Last name Nakashima
Organization	Shin-yurigaoka General Hospital
Division name	Respiratory medicine
Zip code	215-0026
Address	255, Tsuko, Furusawa, Kawasaki Asao-ku, Kanagawa
TEL	044-322-9991
Email	masanao.nakashima@mt.strins.or.jp

Public contact
Name of contact person	1st name Yasihiko Middle name Last name Yoshida
Organization	Nouvelle Place Inc.
Division name	Research Management Office
Zip code	105-0001
Address	Toranomon 33 Mori Building, 3-8-21, Toranomon, Minatoku, Tokyo
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	Shin-yurigaoka General Hospital
Address	255, Tsuko, Furusawa, Kawasaki Asao-ku, Kanagawa
Tel	044-322-9991
Email	tadashi.kanbe@mt.strins.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

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 08 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	37
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	2019 Year 09 Month 09 Day
Date of IRB	2019 Year 09 Month 26 Day
Anticipated trial start date	2019 Year 09 Month 26 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	2021 Year 04 Month 08 Day
Last modified on	2021 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050078

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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