UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032507 |
|---|---|
| Receipt number | R000037076 |
| Scientific Title | Identification of molecular pathology of asthma and COPD exacerbations |
| Date of disclosure of the study information | 2018/05/08 |
| Last modified on | 2024/09/07 09:23:09 |
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Basic information
Public title
Identification of molecular pathology of asthma and COPD exacerbations
Acronym
Identification of molecular pathology of asthma and COPD exacerbations
Scientific Title
Identification of molecular pathology of asthma and COPD exacerbations
Scientific Title:Acronym
Identification of molecular pathology of asthma and COPD exacerbations
Region
| Japan |
Condition
Condition
Asthma
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of molecular pathology of asthma and COPD exacerbations
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sputum differential cell counts
Key secondary outcomes
Sputum cytokine levels
Cell-free plasma DNA concentration
Gene expression levels in sputum cells
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
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
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Hirai |
Organization
School of Pharmaceutical Sciences, University of Shizuoka
Division name
Department of Clinical Pharmacology & Genetics
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
TEL
81-54-264-5674
hiraik@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Hirai |
Organization
Shizuoka General Hospital
Division name
Laboratory of Clinical Pharmacogenomics
Zip code
420-8527
Address
4-27-1, Kita-Ando, Aoi-ku, Shizuoka, 420-8527, Japan
TEL
81-54-247-6111
Homepage URL
hiraik@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shizuoka General Hospital
Address
4-27-1, Kita-Ando, Aoi-ku, Shizuoka, 420-8527, Japan
Tel
81-54-247-6111
chiken-sougou[at]shizuoka-pho.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 08 | 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
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | 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
| 2018 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037076
