UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046599 |
|---|---|
| Receipt number | R000053122 |
| Scientific Title | A multicenter study for gastric lesion detection performance of Computer-Aided-Detection (CADe) program for endoscopy |
| Date of disclosure of the study information | 2022/01/24 |
| Last modified on | 2024/01/15 08:31:31 |
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Basic information
Public title
Performance evaluation of computer-Aided gastric lesion detection program with artificial intelligence (AI) for endoscopy
Acronym
Performance evaluation of computer-Aided gastric lesion detection program for endoscopy
Scientific Title
A multicenter study for gastric lesion detection performance of Computer-Aided-Detection (CADe) program for endoscopy
Scientific Title:Acronym
Performance evaluation of endoscopy CADe program
Region
| Japan |
Condition
Condition
Localized gastric lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the gastric lesion detection performance of the endoscopy CADe program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity of the CADe program for detecting the gastric lesions
Key secondary outcomes
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the total frames of gastric lesions to be analyzed
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo upper gastrointestinal endoscopy at the institutions during the study period.
Key exclusion criteria
Patients who:
- underwent total gastrectomy;
- are under the age of 20;
- do not agree to participate in this study;
- cannot follow instructions of this study and endoscopy and;
- are judged to be inappropriate as a subject of this study by the investigator, for other reasons.
Target sample size
267
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino-shi, Fukuoka
TEL
092-921-101
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino-shi, Fukuoka
TEL
092-921-1011
Homepage URL
yao@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
OLYMPUS Medical Systems Corp
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
Fukuoka University-Medical Ethics Review Board
Address
7-45-1 Nanakuma, Jonan-kuFukuoka 814-0180, JAPAN
Tel
092-801-1011
fumed-ethics@fukuoka-u.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
静岡がんセンター（静岡県）、千葉大学医学部附属病院（千葉県）、
神戸市立医療センター中央市民病院（兵庫県）、
オリンパスメディカルシステムズ株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 24 | 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
77
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | 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
A total of three institutes participating in this joint study including Fukuoka University Chikushi Hospital perform upper gastrointestinal endoscopy. The performance of the endoscopy CADe program is evaluated with videos, which are recorded during the endoscopy after obtaining informed consent from the patients.
Management information
Registered date
| 2022 | Year | 01 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053122
| 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 |
