UMIN-CTR Clinical Trial

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
Email	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
Email	fueta-tky@umin.ac.jp

Sponsor
Institute	National Hospital Organization Tokyo National Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048339