UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049887 |
|---|---|
| Receipt number | R000056809 |
| Scientific Title | Usefulness of computer-aided detection using artificial intelligence for esophageal squamous cell carcinoma in esophagogastroduodenoscopy |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/02/17 18:56:33 |
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Basic information
Public title
Usefulness of computer-aided detection using artificial intelligence for esophageal squamous cell carcinoma in esophagogastroduodenoscopy
Acronym
Esophageal AI Study
Scientific Title
Usefulness of computer-aided detection using artificial intelligence for esophageal squamous cell carcinoma in esophagogastroduodenoscopy
Scientific Title:Acronym
Esophageal AI Study
Region
| Japan |
Condition
Condition
esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the detection ability of computer-aided detection system (CAD EYE) for known esophageal squamous cell carcinomas in esophagogastroduodenoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rates of CAD EYE (LCI-CADe and BLI-CADe) for known esophageal squamous cell carcinomas
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with early esophageal squamous cell carcinomas or suspected esophageal squamous cell carcinomas
Patients scheduled to undergo esophagogastroduodenoscopy at Nagoya University Hospital or participating facilities for the purpose of close examination or endoscopic treatment for early esophageal squamous cell carcinomas or suspected early esophageal squamous cell carcinomas
Patients who have given sufficient explanation for participation in this study, and who have given written consent of their own free will based on sufficient understanding.
Key exclusion criteria
Patients who are deemed inappropriate as research subjects by the principal investigator
Patients who are incapable of consenting
Patients who will not be treated at their own institution
Patients after radiation or radiochemotherapy for esophageal squamous cell carcinomas, radiation for head and neck cancers, esophagectomy, recurrence after treatment, advanced esophageal cancers, or adenocarcinoma of the esophagus
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kawashima |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2172
kazufuru@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Furukawa |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku
TEL
052-744-2172
Homepage URL
kazufuru@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
None
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
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku
Tel
052-741-2111
ethics@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | 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
| 2022 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056809
| 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 |
