UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058804 |
|---|---|
| Receipt number | R000067236 |
| Scientific Title | Development of a computer-aided diagnosis system for qualitative diagnosis of early gastric cancer and verification of its usefulness. |
| Date of disclosure of the study information | 2025/08/14 |
| Last modified on | 2025/08/14 20:48:18 |
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Basic information
Public title
Development of a computer-aided diagnosis system for qualitative diagnosis of early gastric cancer and verification of its usefulness.
Acronym
Development of a computer-aided diagnosis system for qualitative diagnosis of early gastric cancer and verification of its usefulness.
Scientific Title
Development of a computer-aided diagnosis system for qualitative diagnosis of early gastric cancer and verification of its usefulness.
Scientific Title:Acronym
Development of a computer-aided diagnosis system for qualitative diagnosis of early gastric cancer and verification of its usefulness.
Region
| Japan |
Condition
Condition
Gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to construct a CADx system for the qualitative diagnosis of early gastric cancer and validate its usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of depth of invasion
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of gastric adenoma or gastric cancer that underwent endoscopic or surgical treatment at our hospital between April 2020 and April 2024.
Key exclusion criteria
Cases judged as inappropriate by the study investigator.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432227171
matsumura@chiba-u.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Matsubara |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432227171
Homepage URL
matsubaray@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba 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
Chiba University Hospital Clinical Trials Department
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
0432227171
hsp-kansaturinri@chiba-u.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 | 08 | Month | 14 | 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
| 2024 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will collect endoscopic images and pathological information from past medical records to build a CADx system. The diagnostic accuracy of the CADx system for the depth of invasion will be compared with that of experts and trainees.
Management information
Registered date
| 2025 | Year | 08 | Month | 14 | Day |
Last modified on
| 2025 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067236
