UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013697 |
|---|---|
| Receipt number | R000015985 |
| Scientific Title | Cluster analysis in Japanese asthma patients -Multi-institutional joint research- |
| Date of disclosure of the study information | 2014/04/11 |
| Last modified on | 2021/05/03 16:05:05 |
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Basic information
Public title
Cluster analysis in Japanese asthma patients -Multi-institutional joint research-
Acronym
Cluster analysis in Japanese asthma patients
Scientific Title
Cluster analysis in Japanese asthma patients -Multi-institutional joint research-
Scientific Title:Acronym
Cluster analysis in Japanese asthma patients
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Cluster analysis is a method to identify clinically similar group by using various clinical indicators without arbitrariness. The aim of this study is to identify and characterize a refractory, severe group of asthma by cluster analysis. As recent novel clinical parameters, the airway inflammation markers and the parameters from forced oscillation technique are included. In addition, exacerbation or utilization of medical resources in each identified groups will be analyzed and clinically useful clustering will be pursued.
Basic objectives2
Others
Basic objectives -Others
Cluster analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clustered group
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Asthma patients diagnosed by asthma specialist based on GINA guideline
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Ohta |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Director
Zip code
Address
Takeoka 3-1-1, Kiyose city, Tokyo, Japan
TEL
042-491-2111
kenohta@tokyo-hosp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nagase |
Organization
Teikyo University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
Kaga 2-11-1, Itabashi-ku, Tokyo, Japan
TEL
03-3964-8351
Homepage URL
nagaseh@med.teikyo-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2014 | Year | 04 | Month | 11 | 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
| 2013 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information (history, comorbidity, treatment, symptoms)
Pulmonary function test
Forced oscillation technique
Total and specific IgE
Airway inflammation markers
Management information
Registered date
| 2014 | Year | 04 | Month | 11 | Day |
Last modified on
| 2021 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015985
