UMIN-CTR Clinical Trial

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
Email	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
Email	ntana@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto Univeresity, Kyoto University Hospital, Department of 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	Kyoto University Ethics Committee
Address	54 Kawahara, Shogoin, Sakyo-ku, Kyoto, Japan
Tel	0757534680
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032496