UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042342 |
|---|---|
| Receipt number | R000048339 |
| Scientific Title | Blood metabolome profiling for phenotyping severe asthma in Japan |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2022/04/06 10:15:20 |
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Basic information
Public title
Blood metabolome profiling for phenotyping severe asthma in Japan
Acronym
NHOM-metabolomics
Scientific Title
Blood metabolome profiling for phenotyping severe asthma in Japan
Scientific Title:Acronym
NHOM-metabolomics
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify metabolome profile among severe asthma in Japan.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to identify metabolome profile among severe asthma in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metabolome profiling among severe asthma phenotypes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Asthma
(1) severe asthma
(2) patient visiting participating hospitals
(3) patient with informed consent
(4) age above 16
Healthy Control
(1) age above 16
(2) subject with informed consent
(3) subject without any disease
Key exclusion criteria
subject whom the investigator thinks not appropriate for participation in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka
TEL
042-491-2111
fueta-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka
TEL
042-491-2111
Homepage URL
fueta-tky@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization IRB
Address
2-5-21 Higashigaoka, Meguro-Ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.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
| 2020 | Year | 11 | 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
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 11 | Month | 04 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048339
