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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042231
Receipt No. R000048174
Scientific Title Multi-omics analysis of Eosinophils and Neutrophils in Asthma and COPD Overlap(ACO).
Date of disclosure of the study information 2020/10/26
Last modified on 2020/10/26

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Basic information
Public title Multi-omics analysis of Eosinophils and Neutrophils in Asthma and COPD Overlap(ACO).
Acronym Multi-omics analysis of Eosinophils and Neutrophils in Asthma and COPD Overlap(ACO).
Scientific Title Multi-omics analysis of Eosinophils and Neutrophils in Asthma and COPD Overlap(ACO).
Scientific Title:Acronym Multi-omics analysis of Eosinophils and Neutrophils in Asthma and COPD Overlap(ACO).
Region
Japan

Condition
Condition Asthma and COPD Overlap(ACO)
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify new biomarkers and clarify the mechanism of ACO with multi-omics analysis of eosinophils and neutrophils in patiens.
Basic objectives2 Others
Basic objectives -Others To investigate the possibility of developing new drugs and biomarkers.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Investigation of characteristics and biomarkers of in ACO patiens.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Healthy subjects, COPD and ACO patients aged 20 to 80 years old at the time of consent (regardless of gender).
Subjects who understand the content of this study and can obtain written consent at their own free will.
Key exclusion criteria Subjects who cannot perform appropriate respiratory function tests due to cognitive decline or complications.
The attending physicians determine that it is inappropriate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Fukunaga
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine, Department of Medicine
Zip code 1608582
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL 0333531211
Email kfukunaga@keio.jp

Public contact
Name of contact person
1st name Shotaro
Middle name
Last name Chubachi
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine, Department of Medicine
Zip code 1608582
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL 0333531211
Homepage URL
Email bachibachi472000@z6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor RIKEN Center for Integrative Medical Sciences(Metabolome reserch team)
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine
Address 35 Shinanomachi, Shinuku-ku, Tokyo, Japan
Tel 0333531211
Email natsuko.chiba@adst.keio.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 Y2020-038
Org. issuing International ID_1 RIKEN Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 26 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 Enrolling by invitation
Date of protocol fixation
2020 Year 07 Month 28 Day
Date of IRB
2020 Year 07 Month 28 Day
Anticipated trial start date
2020 Year 07 Month 28 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a single-center observation cross-sectional study.

Management information
Registered date
2020 Year 10 Month 26 Day
Last modified on
2020 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048174

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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