UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028387 |
|---|---|
| Receipt number | 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 | 2022/03/31 15:03:50 |
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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
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Tanabe |
Organization
Kyoto University Hospital
Division name
Department of Respiratory medicine
Zip code
606-8507
Address
54 Kawahara, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
ntana@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Tanabe |
Organization
Kyoto University Hospital
Division name
Respiratory medicine
Zip code
606-8507
Address
54 Kawahara, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
Homepage URL
ntana@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto Univeresity, Kyoto University Hospital, Department of Respiratory Medicine
Institute
Department
Personal name
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
Kyoto University Ethics Committee
Address
54 Kawahara, Shogoin, Sakyo-ku, Kyoto, Japan
Tel
0757534680
ethcom@kuhp.kyoto-u.ac.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
京都大学医学部附属病院、寺田内科呼吸器科（兵庫県姫路市）
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
330
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
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 07 | Day |
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
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032496
