UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042231 |
|---|---|
| Receipt number | 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 10:05:43 |
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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
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
bachibachi472000@z6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
