UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032811 |
|---|---|
| Receipt number | R000037215 |
| Scientific Title | The role of MostGraph in the diagnosis of cough variant asthma |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2022/12/03 17:25:50 |
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Basic information
Public title
The role of MostGraph in the diagnosis of cough variant asthma
Acronym
The role of MostGraph in the diagnosis of cough variant asthma
Scientific Title
The role of MostGraph in the diagnosis of cough variant asthma
Scientific Title:Acronym
The role of MostGraph in the diagnosis of cough variant asthma
Region
| Japan |
Condition
Condition
cough variant asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the usefulness of the MostGraph in the diagnosis of cough variant asthma.
Basic objectives2
Others
Basic objectives -Others
research of sensitivity and specificity in the diagnosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity and the specificity in the diagnosis of cough variant asthma using MostGraph.
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
First visit patients from January 2013 to December 2017 at Yokohama City Minato Red Cross Hospital who underwent Monograph and methacholine airway responsiveness test (astograph).
Key exclusion criteria
(1) Patients received steroid treatments (including inhalation) or immunosuppressive therapy within 1 month.
(2) Patients with lung cancer or interstitial pneumonitis.
(3) Patients with severe hepatic, kidney, cardiac, blood or other severe complications.
(4)Patients who are considered inappropriate by attending physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sumi |
Organization
Tokyo Medical and Dental University
Division name
Respiratory and Nervous System Science
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035372
sumi-alg@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sumi |
Organization
Tokyo Medical and Dental University
Division name
Respiratory and Nervous System Science
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035372
Homepage URL
sumi-alg@umin.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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TMDU BERC
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4085
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 01 | 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
| 2018 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively collected clinical informations and results of pulmonary function tests from medical records.
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037215
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
