UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037979 |
|---|---|
| Receipt number | R000043293 |
| Scientific Title | Exploratory research of COPD clinical stratification by Radwisp.-prospective observational study- |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2020/09/16 12:51:16 |
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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
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
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
ya-yoshida@m3.com
Sponsor or person
Institute
Mediotto. Inc
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043293
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
