UMIN-CTR Clinical Trial

Basic information
Public title	Phenotype classification of COPD
Acronym	COPD Phenotype
Scientific Title	Phenotype classification of COPD
Scientific Title:Acronym	COPD Phenotype
Region	Japan

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

Objectives
Narrative objectives1	Phenotype analysis of COPD.
Basic objectives2	Others
Basic objectives -Others	Phenotype classification of chronic obstructive pulmonary disease by clinical findings, laboratory findings, imaging findings, and to search for a biomarker.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	classify
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	A.Patients with COPD at Tokyo Medical and Dental University Hospital. (n=30) B.Patients with COPD at Okinawa Prefectural Chubu Hospital. (n=30) C. Patients without COPD at Tokyo Medical and Dental University Hospital or Okinawa Prefectural Chubu Hospital.(n=30)
Key exclusion criteria	(1) Patients with severe liver, kidney disease, heart disease, hematologic disease, or severe complications. (2) Patients whom doctors determined to be inappropriate as a subject.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Sumi Middle name Last name Yuki
Organization	Tokyo Medical and Dental University
Division name	School of health sciences, Faculty of Medicine. Biofunctional Informatics, Biomedical Laboratory Science
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL	03-3813-6111
Email	ysumi.pulm@tmd.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Sumi
Organization	Tokyo Medical and Dental University
Division name	School of health sciences, Faculty of Medicine. Biofunctional Informatics, Biomedical Laboratory Sci
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL	03-3813-6111
Homepage URL
Email	ysumi.pulm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental 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	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
Tel	03-3813-6111
Email	info.bec@tmd.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	東京医科歯科大学医学部附属病院(東京都)、沖縄県立中部病院(沖縄県) Tokyo Medical and Dental University Hospital, Okinawa Prefectural Chubu Hospital.

Other administrative information
Date of disclosure of the study information	2016 Year 04 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	Completed
Date of protocol fixation	2016 Year 02 Month 14 Day
Date of IRB	2016 Year 03 Month 22 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patient profile, physical examination, Chest CT imaging, blood sampling results, collected lung function tests, the serum are collected.

Management information
Registered date	2016 Year 02 Month 14 Day
Last modified on	2020 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024196