UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058226 |
|---|---|
| Receipt number | R000066568 |
| Scientific Title | A prospective observational study to investigate the usefulness of an artificial intelligence-based endoscopic image diagnosis support system for rare upper gastrointestinal cancers |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/19 18:24:00 |
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Basic information
Public title
A prospective observational study to investigate the usefulness of an artificial intelligence-based endoscopic image diagnosis support system for rare upper gastrointestinal cancers
Acronym
The usefulness of AI endoscopy for rare upper gastrointestinal cancers
Scientific Title
A prospective observational study to investigate the usefulness of an artificial intelligence-based endoscopic image diagnosis support system for rare upper gastrointestinal cancers
Scientific Title:Acronym
The usefulness of AI endoscopy for rare upper gastrointestinal cancers
Region
| Japan |
Condition
Condition
Recurrent cancer after radiation therapy
Esophagogastric junction cancer/Barrett's cell carcinoma
Cancer in the mucosa behind achalasia
Undifferentiated gastric cancer without Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Using the upper endoscopy image diagnosis support program (EW10-EG02) for detection installed in the endoscopic image diagnosis support system (CAD EYE), we will verify the performance (mainly sensitivity) of the following four rare types of cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of CAD EYE (LCI-CADe and BLI-CADe) for known upper gastrointestinal cancers
Key secondary outcomes
Characteristics of known lesions detected/not detected by LCI-CADe or BLI-CADe
Survey items
CAD EYE detection results
Information about lesions (number, location [direction, circumferential distribution, etc.], shape (protruding, flat, depressed), etc.)
Pathology results
Other information (patient information, surgeon information, endoscopic examination information, etc.)
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 scheduled to undergo upper gastrointestinal endoscopy for the following cancers or suspected cancer lesions at our university
- Recurrent cancer after radiation therapy
- Esophagogastric junction cancer/Barrett's cell carcinoma
- Cancer in the mucosa behind achalasia
- Undifferentiated gastric cancer not infected with Helicobacter pylori
Key exclusion criteria
- Patients who the principal investigator judges to be unsuitable as study subjects
- Patients who are unable to consent
- Minors
- Patients who do not undergo treatment at their own facility
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | TAKAO |
| Middle name | |
| Last name | MAEKITA |
Organization
School of Medicine, Wakayama Medical University
Division name
Department of 2nd Internal Medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama, Wakayama
TEL
+81-73-447-2300
maekita@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | TAKAO |
| Middle name | |
| Last name | MAEKITA |
Organization
School of Medicine, Wakayama Medical University
Division name
Department of 2nd Internal Medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama, Wakayama
TEL
+81-73-447-2300
Homepage URL
maekita@wakayama-med.ac.jp
Sponsor or person
Institute
School of Medicine, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Medicine, Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama
Tel
+81-73-447-2300
maekita@wakayama-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
| 2025 | Year | 06 | Month | 20 | 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
| 2025 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective study
Target number of cases: 40 cases
Primary item: Detection rate of CAD EYE (LCI-CADe and BLI-CADe) for known upper gastrointestinal cancer
Secondary item: Characteristics of known lesions detected/not detected by LCI-CADe or BLI-CADe
Survey items are:
- CAD EYE detection results
- Information on lesions (number, location [direction, circumferential location, etc.], shape (protruding, flat, depressed), etc.)
- Pathological results
- Other information (patient information, surgeon information, endoscopic examination information, etc.)
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066568
