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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028387
Receipt No. R000032496
Scientific Title Longitudinal observational study to explore roles of inpitartory and expiratory CT scans in COPD patients
Date of disclosure of the study information 2017/08/01
Last modified on 2017/07/26

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Basic information
Public title Longitudinal observational study to explore roles of inpitartory and expiratory CT scans in COPD patients
Acronym Roles of inspiratory and expiratory CT scans in COPD
Scientific Title Longitudinal observational study to explore roles of inpitartory and expiratory CT scans in COPD patients
Scientific Title:Acronym Roles of inspiratory and expiratory CT scans in COPD
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To understand whether longitudinal assessment of emphysema and small airway diesase by using inspiratory and expiratory CT scans allows for prediction of clinical outcomes in patients with COPD
Basic objectives2 Others
Basic objectives -Others To test correlations between the severity of emphysema and small airway disease assessed longidtudinally by inspiratory and expiratory CT scans, and clinical outcomes including symptom, lung function, and prognosis in patients with COPD
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To assess if there are correlations between long-term (up to 6 years) changes in emphysema and small airway disease assessed by inspiratory and expiratory CT scans and clinical deteriolaton in patients with COPD.
Key secondary outcomes To test correlations between structural abnormality assessed by CT scans and clnical conditions at study enrollment

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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria fullfill diagnosis of COPD
Key exclusion criteria a history of lung surgery or malignancy
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shigeo Muro
Organization Kyoto University Hospital
Division name Respiratory medicine
Zip code
Address 54 Kawahara, Shogoin, Sakyo-ku, Kyoto, Japan
TEL 075-751-3830
Email smuro@kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Naoya Tanabe
Organization Kyoto University Hospital
Division name Respiratory medicine
Zip code
Address 54 Kawahara, Shogoin, Sakyo-ku, Kyoto, Japan
TEL 075-751-3830
Homepage URL
Email ntana@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto Univeresity, Kyoto University Hospital, Respiratory Medicine
Institute
Department

Funding Source
Organization Kyoto University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In addtion to regular clincal practice, inspiratory and expiratory CT scans will be performed at every 2 year.

Management information
Registered date
2017 Year 07 Month 26 Day
Last modified on
2017 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032496

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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