UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009968 |
|---|---|
| Receipt number | 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 14:21:54 |
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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
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
atsuta@juntendo.ac.jp
Sponsor or person
Institute
juntendo university graduate school of medicine, Department of respiratory medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011674
