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

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 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

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

Value
https://center6.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