UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051034 |
|---|---|
| Receipt number | R000058169 |
| Scientific Title | Development of artificial intelligence for diagnosis and treatment of lung cancer |
| Date of disclosure of the study information | 2023/05/11 |
| Last modified on | 2023/05/11 00:11:17 |
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Basic information
Public title
Development of artificial intelligence for diagnosis and treatment of lung cancer
Acronym
Development of artificial intelligence for diagnosis and treatment of lung cancer
Scientific Title
Development of artificial intelligence for diagnosis and treatment of lung cancer
Scientific Title:Acronym
Development of artificial intelligence for diagnosis and treatment of lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are: 1) to develop artificial intelligence (AI) to distinguish between benign and malignant pulmonary nodules using CT images, 2) to verify the molecular characteristics of malignant lung tumors based on CT images, and 3) to develop AI systems to support bronchoscopy by combining CT images, X-ray fluoroscopic images, and bronchoscopic images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy in distinguishing benign and malignant pulmonary tumors utilizing artificial intelligence
Key secondary outcomes
Accuracy of the proportion of pathological invasion factors with artificial intelligence
Reproducibility and objectivity of image parameters during 3D image analysis with artificial intelligence
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)Aged 18 years or older
(2)Patients who undergo HRCT imaging to diagnose a thoracic tumor and who will undergo at any least of the following: biopsy or surgery or post-operative pathology
Key exclusion criteria
Patients who did not provide consent to participate in the study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Norihiko |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Medical University Hospital
Division name
Department of Surgery
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
ikeda-n@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yujin |
| Middle name | |
| Last name | Kudo |
Organization
Tokyo Medical University Hospital
Division name
Department of Surgery
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
Homepage URL
ykudo@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
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
Tokyo Medical University
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
Tel
0333426111
adm_irb@tokyo-med.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
| 2023 | Year | 05 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2023 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058169
