UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022340 |
|---|---|
| Receipt number | R000025750 |
| Scientific Title | Phenotypic classification of cough variant asthma / asthma using the Mostgraph |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2022/11/22 09:40:59 |
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Basic information
Public title
Phenotypic classification of cough variant asthma / asthma using the Mostgraph
Acronym
Phenotypic classification of cough variant asthma / asthma using the Mostgraph
Scientific Title
Phenotypic classification of cough variant asthma / asthma using the Mostgraph
Scientific Title:Acronym
Phenotypic classification of cough variant asthma / asthma using the Mostgraph
Region
| Japan |
Condition
Condition
Patients with cough
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Perform phenotypic classification of patients with bronchial asthma complaining of cough / cough variant asthma using cluster analysis.
Basic objectives2
Others
Basic objectives -Others
Clarify the role of the Mostgraph as a biomarker in the diagnosis of bronchial asthma / cough asthma.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phenotype classification by cluster analysis
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited at Ikebukuro Otani clinic and were performed general pulmonary function testing, blood examination, Mostgraph examination, and FeNO examination at the first visit.
Key exclusion criteria
(1) Patients receiving a steroid treatment (including inhalation), asthma treatments, or immunosuppressive therapy within one month.
(2) Patients with lung cancer, interstitial pneumonia.
(3) Patients with severe liver, kidney, heart, blood, and other diseases.
(4) Patients who were judged to be inappropriate as a subject by the attending physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sumi |
Organization
Tokyo Medical and Dental University
Division name
Biofunctional Informatics, School of health sciences, Faculty of Medicine.
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
03-3813-6111
ysumi.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sumi |
Organization
Tokyo Medical and Dental University
Division name
Biofunctional Informatics, School of health sciences, Faculty of Medicine.
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
03-3813-6111
Homepage URL
ysumi.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
Tel
03-3813-6111
info.bec@tmd.ac.jp
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
池袋大谷クリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
422
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
Main results already published
Date of protocol fixation
| 2016 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient profile, the results of physical examination, imaging tests, blood examinations, mostgraph examination, lung function tests, and exhaled nitric oxide concentration (FeNO) testing will be collected.
Management information
Registered date
| 2016 | Year | 05 | Month | 18 | Day |
Last modified on
| 2022 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025750
