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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043868
Receipt No. R000050078
Scientific Title Exploratory research of COPD clinical stratification by Radwisp.-prospective observational study-
Date of disclosure of the study information 2021/04/08
Last modified on 2021/04/08

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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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