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 | 2025/06/05 09:39:06 |
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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
https://www.nature.com/articles/s41598-023-48042-3
Publication of results
Partially published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-023-48042-3
Number of participants that the trial has enrolled
1156
Results
Although reference ranges of Mostgraph were established, patients with asthma could not be discriminated from controls. However, with deep learning, we could discriminate between the two groups with 78% accuracy. Therefore, deep learning, which considers multiple measurements as a whole, was more effective in interpreting MostGraph measurement results than use of reference ranges, which considers each result individually.
Results date posted
| 2025 | Year | 06 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy participants over 16 years of age were recruited between September 2013 and May 2022 in the following three ways: (i) from among those attending a medical checkup at the Medical Check-up Center of Yokohama City Minato Red Cross Hospital. Healthy participants with normal chest radiographic findings in the previous annual medical checkup before the study entry were chosen. (ii) Healthy medical staff of the Medical Check-up Center of Yokohama City Minato Red Cross Hospital, with no respiratory diseases and normal chest radiographic findings during the annual medical checkup, were recruited. (iii) Healthy staff or students of Tokyo Medical and Dental University (TMDU), with no respiratory diseases and normal chest radiographic findings during the annual medical checkup, were additionally recruited.
Patients with asthma/CVA more than 16 years old were recruited retrospectively, from September 2013 to June 2021, in the following three ways: (i) from amongst those visiting the Allergy Center of Yokohama City Minato Red Cross Hospital; (ii) from amongst those visiting the Ikebukuro Otani Clinic; and (iii) from amongst those visiting the Shibata Ekimae Hiratanaika Clinic. For the inclusion, they were the first visit patients who were given final diagnosis of asthma based on the Japanese guidelines for adult asthma14,15,16,17. They had had no previous treatments for asthma and underwent MostGraph measurement via pulse wave pressure. The following were included in the study: (i) current smokers, ex-smokers, and non-smokers; (ii) participants with diseases not related to the respiratory system, such as hypertension, hyperlipidemia, gout, and diabetes mellitus. The patients were excluded if they had severe diseases like cancer, comorbid lung diseases, or infectious diseases including common cold or bronchitis.
Participant flow
Normal healthy subjects who had showen informed consent underwent FENO, Mostograph, and spirometry tests. The results were provided to them with an explanation.
Asthma/cough-variant asthma patients underwent routine medical treatment and patient data was collected retrospectively. A notice was posted in the clinic informing them that the data would be anonymized and used for research, and that people who did not want their data to be used could request this.
These methods were reviewed and approved by the ethical committee.
Adverse events
not repoeted
Outcome measures
discriminating accuracy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037215
