UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053885 |
|---|---|
| Receipt number | R000061496 |
| Scientific Title | A Study on the development of image diagnosis technology using artificial intelligence (AI) for Chest X-ray |
| Date of disclosure of the study information | 2024/03/18 |
| Last modified on | 2024/03/18 13:08:29 |
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Basic information
Public title
A Study on the development of image diagnosis technology using artificial intelligence (AI) for Chest X-ray
Acronym
A Study on the development of image diagnosis technology using artificial intelligence (AI) for Chest X-ray
Scientific Title
A Study on the development of image diagnosis technology using artificial intelligence (AI) for Chest X-ray
Scientific Title:Acronym
A Study on the development of image diagnosis technology using artificial intelligence (AI) for Chest X-ray
Region
| Japan |
Condition
Condition
subjects with thoracic diseases
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to perform chest X-ray examinations on individuals with thoracic diseases and compare and validate the interpretations between physician readings and artificial intelligence (AI) diagnosis.
Basic objectives2
Others
Basic objectives -Others
Compare thoracic diseases diagnosed through patient interviews with those diagnosed by AI, and validate the proportion of agreement.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the interpretation results by physicians with the diagnostic outcomes by AI, and validate the proportion of agreement.
Key secondary outcomes
Compare thoracic diseases diagnosed through patient interviews with those diagnosed by AI, and validate the proportion of agreement.
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
1) Japanese male and female aged 18 years and older at the time of consent acquisition.
2) An individual with any of the following thoracic diseases.
pneumonia, interstitial pneumonia, bronchiolitis obliterans organizing pneumonia (BOOP), pulmonary abscess, pulmonary tuberculosis, atypical mycobacterial infection, pulmonary fungal infection, bronchiectasis, bronchiolitis, lung cancer, metastatic lung tumor, pleural tumor, mediastinal tumor, pulmonary fibrosis, pneumoconiosis, pulmonary alveolar proteinosis, pulmonary embolism, pulmonary arteriovenous fistula, pleurisy, empyema*, pneumothorax, pulmonary emphysema, mediastinal emphysema
*Settings to confirm that there are no abnormalities in the chest X-ray image even though it is not a chest disease.
3)Those who have received sufficient explanation about the purpose and content of the study and have signed the consent form before the start of the examination.
Key exclusion criteria
Individuals deemed inappropriate by the principal investigator for the examination and the sub investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kinbara |
Organization
Random Square Co., Ltd
Division name
IT dev.
Zip code
812-0027
Address
1-3 Shimokawabata-matchi,Hakata-ku,Fukuoka,Fukuoka,Japan
TEL
092-282-0118
kimbara.toshiyuki@randomsq.co.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Otake |
Organization
feileB Co., Ltd
Division name
Clinical Research Support dev.
Zip code
170-0013
Address
1-18-1 Higashiikebukuro Toshima-ku Tokyo Japan
TEL
03-4332-1770
Homepage URL
otake@feileb.jp
Sponsor or person
Institute
Random Square Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Random Square Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NISHI-UMEDA Clinic for Asian Medical Collaboration Ethics Review Committee
Address
Maruit Nishi-Umeda Building 3F, 3-3-45 Umeda, Kita-ku, Osaka, Osaka, Japan
Tel
06-4797-5660
nouchi@amc-clinic.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
| 2024 | Year | 03 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gender, age, height, weight, medical history,Imaging findings
Management information
Registered date
| 2024 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061496
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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