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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009968
Receipt No. R000011674
Scientific Title Juntendo University, Biomarker Discovery in Asthma
Date of disclosure of the study information 2013/02/06
Last modified on 2015/12/26

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Basic information
Public title Juntendo University, Biomarker Discovery in Asthma
Acronym Juntendo University, Biomarker Discovery in Asthma
Scientific Title Juntendo University, Biomarker Discovery in Asthma
Scientific Title:Acronym Juntendo University, Biomarker Discovery in Asthma
Region
Japan

Condition
Condition Asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main objective of this study was to elucidate whether CD27+ CD4+ T-cell population are biomarker for asthma.
Basic objectives2 Others
Basic objectives -Others Biomarker discovery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biomarker discovery in asthma
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

Not applicable
Gender Male and Female
Key inclusion criteria Subject is diagnosed with Asthma and COPD according to the Japanese Asthma Prevention and Management Guidelines (JGL) and Guidelines for the Diagnosis and Treatment of COPD 3rd. ed., respectively. Subject has signed the informed concent form.
Key exclusion criteria Exclusion criteria included interstitial pneumonia, infectious disease, and active cancer.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Atsuta
Organization juntendo university graduate school of medicine
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku,,Tokyo, Japan
TEL 03-3813-3111
Email atsuta@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Atsuta
Organization juntendo university graduate school of medicine
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku,,Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email atsuta@juntendo.ac.jp

Sponsor
Institute juntendo university graduate school of medicine, Department of respiratory medicine
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2013 Year 02 Month 06 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
2013 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Relation with each candidate of biomarker and the severity of asthma is analyzed by cross-sectional method.

Management information
Registered date
2013 Year 02 Month 05 Day
Last modified on
2015 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011674

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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