UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021013 |
|---|---|
| Receipt number | R000024196 |
| Scientific Title | Phenotype classification of COPD |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2020/02/17 10:44:38 |
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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
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
ysumi.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024196
