UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057890 |
|---|---|
| Receipt number | R000066165 |
| Scientific Title | A non-randomized confirmatory trial of computer aided detection for gastric epithelial tumor using ultrathin endoscope |
| Date of disclosure of the study information | 2025/05/21 |
| Last modified on | 2025/05/17 00:03:22 |
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Basic information
Public title
A non-randomized confirmatory trial of computer aided detection for gastric epithelial tumor using ultrathin endoscope
Acronym
A non-randomized confirmatory trial of computer aided detection for gastric epithelial tumor using ultrathin endoscope
Scientific Title
A non-randomized confirmatory trial of computer aided detection for gastric epithelial tumor using ultrathin endoscope
Scientific Title:Acronym
A non-randomized confirmatory trial of computer aided detection for gastric epithelial tumor using ultrathin endoscope
Region
| Japan |
Condition
Condition
Gastric epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the detection ability of computer-aided detection system for known gastric epithelial tumor during esophagogastroduodenoscopy using ultrathin endoscope
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rates of CADe (WLI and LCI) for known gastric epithelial tumors
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patient with known gastric epithelial tumors scheduling endoscopic examination or treatment
2) Gastric epithelial tumors diagnosed as gastric epithelial tumors (Group3, Group4 or Group5) from biopsy specimen
3) Patients who have given written consent of their own free will based on sufficient understanding
Key exclusion criteria
1) Patients who are deemed inappropriate as researched subjects by the principal investigator
2) Patients with advanced gastric cancer
3) Patients with severe stricture which is incapable of endoscopic insertion
4) Patients with residual or recurrent gastric cancer
5) Patients with contraindication of biopsy due to antithrombotic agents
6) Women in the pregnant or lactation period
Target sample size
197
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ueno |
Organization
Jichi Medical University
Division name
Department of Medicine, Division of Gastroenterology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7348
m05012tu@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ueno |
Organization
Jichi Medical University
Division name
Department of Medicine, Division of Gastroenterology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7348
Homepage URL
m05012tu@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical 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
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
Tel
0285-44-2111
rinri@jichi.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 | 05 | Month | 21 | 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 | 09 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 05 | 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
multi-center, prospective observational study
Management information
Registered date
| 2025 | Year | 05 | Month | 17 | Day |
Last modified on
| 2025 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066165
