UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016694 |
|---|---|
| Receipt number | R000019228 |
| Scientific Title | A Prospective Study of the Relationship among Asthma and COPD Phenotypes, Endotypes, and Genotypes for Personalized Medicine |
| Date of disclosure of the study information | 2015/03/05 |
| Last modified on | 2018/09/04 09:08:30 |
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Basic information
Public title
A Prospective Study of the Relationship among Asthma and COPD Phenotypes, Endotypes, and Genotypes for Personalized Medicine
Acronym
A-SCOPE study
Scientific Title
A Prospective Study of the Relationship among Asthma and COPD Phenotypes, Endotypes, and Genotypes for Personalized Medicine
Scientific Title:Acronym
A-SCOPE study
Region
| Japan |
Condition
Condition
Asthma
COPD
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to evaluate the association of phenotypes (asthma, COPD, and asthma-COPD overlap), endotypes (cytokine levels), and genotypes (related gene polymorphisms) with the outcomes.
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exacerbation of asthma or COPD within one year
Key secondary outcomes
symptom scores, lung function, fractional exhaled nitric oxide,
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
Clinical diagnosis of asthma and/or COPD
Patients receiving current drug therapy in asthma or COPD have no change in drug treatment during 8-week
Key exclusion criteria
Patients who have received anticancer agents within the last 6 months
Patients undergoing immunosuppressive therapy with steroids such as in diseases other than asthma or COPD
Patients suffering from infection or patients with infection is suspected
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keita Hirai |
Organization
Shizuoka General Hospital
Division name
Laboratory of Clinical Pharmacogenomics
Zip code
Address
4-27-1 Kita Ando Aoi-ku Shizuoka, Shizuoka, Japan
TEL
054-247-6111
hiraik@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keita Hirai |
Organization
University of Shizuoka
Division name
Department of clinical pharmacology and genetics, school of pharmaceutical science
Zip code
Address
52-1 Yada Suruga-ku Shizuoka, Shizuoka, Japan
TEL
054-264-5674
Homepage URL
hiraik@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Laboratory of Clinical Pharmacogenomics, Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shizuoka General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
静岡県立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2015 | Year | 03 | Month | 03 | Day |
Last modified on
| 2018 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019228
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
