UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051923 |
|---|---|
| Receipt number | R000059240 |
| Scientific Title | AI diagnostic assistance for central bronchial lesions in bronchoscopy examination |
| Date of disclosure of the study information | 2023/08/16 |
| Last modified on | 2024/10/25 15:30:12 |
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Basic information
Public title
AI diagnostic assistance for central bronchial lesions in bronchoscopy examination
Acronym
AI diagnostic assistance for central bronchial lesions in bronchoscopy examination
Scientific Title
AI diagnostic assistance for central bronchial lesions in bronchoscopy examination
Scientific Title:Acronym
AI in bronchoscopy diagnosis
Region
| Japan |
Condition
Condition
central bronchial lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis of benign/malignant central lesions by AI
Basic objectives2
Others
Basic objectives -Others
Determination of tissue type, eGFR, PD-L1, etc. for malignant tumors
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic sensitivity and specificity for malignant tumors
Key secondary outcomes
Presence or absence of EGFR mutation, degree of PD-L1 TPS
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent bronchoscopy for central lesions
Key exclusion criteria
1. Pathologic diagnosis unknown; 2. Poor endoscopic findings; 3. Other (data incomplete, patient opt-out, etc.).
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Hao |
| Middle name | |
| Last name | Chen |
Organization
Yokohama City University
Division name
Department of pulmonary
Zip code
236-0004
Address
3-9 Fukuura Kanazawa District Yokohama CIty
TEL
045-787-2511
chinsmd@gmail.com
Public contact
Name of contact person
| 1st name | Hao |
| Middle name | |
| Last name | Chen |
Organization
Yokohama CIty Univeristy
Division name
Department of pulmonary
Zip code
2300004
Address
3-9 Fukuura Kanazawa District Yokohama CIty
TEL
045-787-2511
Homepage URL
chinsmd@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama CIty University IRB
Address
3-9 Fukuura Kanazawa District Yokohama CIty
Tel
045-787-2511
chinsmd@gmail.com
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 | 08 | Month | 16 | 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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not available
Management information
Registered date
| 2023 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059240
