UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049204 |
|---|---|
| Receipt number | R000056028 |
| Scientific Title | Evaluation of precision diagnosis using artificial intelligence (AI) diagnostic software for chest X-ray: For practical use in medical and health care for lung cancer treatment |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2022/10/13 06:27:25 |
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Basic information
Public title
Evaluation of precision diagnosis using artificial intelligence (AI) diagnostic software for chest X-ray: For practical use in medical and health care for lung cancer treatment
Acronym
Evaluation of precision diagnosis using artificial intelligence (AI) diagnostic software for chest X-ray: For practical use in medical and health care for lung cancer treatment
Scientific Title
Evaluation of precision diagnosis using artificial intelligence (AI) diagnostic software for chest X-ray: For practical use in medical and health care for lung cancer treatment
Scientific Title:Acronym
Evaluation of precision diagnosis using artificial intelligence (AI) diagnostic software for chest X-ray: For practical use in medical and health care for lung cancer treatment
Region
| Japan |
Condition
Condition
Respiratory disease
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Improvement and evaluation of medical imaging analysis software - EIRL X-Ray Lung nod
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Regarding to Ministry of Health, Labour and Welfare recommending "the process index in the lung cancer examination", we aim recall rate 3% or less, lung cancer discovery rate 0.03% or more, and Positive Predictive Value 1.3% or more
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The case that a normal X-rays diagnosis can enforce
The image that 1750x1750 pixel is more than it in resolution of the X-rays image which I used for shooting
Key exclusion criteria
The image that image quality and a shooting condition have a problem
It is the image with the defect in DICOM information
The image which a manager for study studied it and judged to be inappropriate
Target sample size
31000
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hirano |
Organization
Todachuo Healthcare Center
Division name
Healthcare Center
Zip code
335-0022
Address
2-32-20, Kamitoda, Toda, Saitama
TEL
048-442-1118
t_hirano@tmg.or.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Saji |
Organization
St. Marianna University School of Medicine
Division name
Chest Surgery
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
saji-q@ya2.so-net.ne.jp
Sponsor or person
Institute
lpixel inc.
Institute
Department
Personal name
Funding Source
Organization
lpixel inc.
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
Todachuo General Hospital
Address
1-19-3, Honmachi, Toda, Saitama
Tel
0570-01-1114
t_hirano@tmg.or.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
| 2022 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2022 | Year | 10 | Month | 13 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056028
| 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 |
