UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060929 |
|---|---|
| Receipt number | R000069727 |
| Scientific Title | A Prospective Non-Inferiority Trial Comparing AI-Assisted Conventional Endoscopy with Expert Magnifying Endoscopy for the Detection of Esophageal and Gastric Neoplasms |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/13 17:05:11 |
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Basic information
Public title
A Prospective Study on the Utility of an Artificial Intelligence-Based Detection System for Esophageal and Gastric Tumors
Acronym
EAGLE study
Scientific Title
A Prospective Non-Inferiority Trial Comparing AI-Assisted Conventional Endoscopy with Expert Magnifying Endoscopy for the Detection of Esophageal and Gastric Neoplasms
Scientific Title:Acronym
AIM-UGI Study
Region
| Japan |
Condition
Condition
Esophageal Cancer, Gastric Cancer, Gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to demonstrate the non-inferiority of the sensitivity for detecting early esophageal and gastric cancers by screening endoscopists using conventional endoscopy with AI assistance compared with expert endoscopists using magnifying endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity for detecting esophageal and gastric neoplasms in the screening endoscopist group using a standard upper gastrointestinal endoscope with AI assistance compared with the expert endoscopist group using a magnifying endoscope (Sensitivity was defined as the number of esophageal squamous cell carcinomas, gastric adenomas, and gastric adenocarcinomas detected in each examination divided by the total number of these lesions identified by the referring physician and during the first and second study examinations).
Key secondary outcomes
Diagnostic accuracy for esophageal and gastric cancers (discriminative performance [sensitivity, specificity, positive predictive value, and negative predictive value], and accuracy of depth-of-invasion assessment). Analysis of lesions that were difficult to detect with each endoscopy (including lesion location, tumor type, and macroscopic size).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with confirmed esophageal or gastric cancer will undergo endoscopic examination using a conventional esophagogastroduodenoscopy (EG-860R) combined with an AI-based image diagnostic support system (CADEYE). The examination will be performed by screening endoscopists who have passed the Jikei University certification examination, are qualified to independently perform esophagogastroduodenoscopy, and have experience with fewer than 100 endoscopic treatments for esophageal and gastric cancers.Subsequently, with the AI system (CADEYE) turned off, an expert endoscopist will perform the examination using a magnifying endoscope (EG-860Z). Expert endoscopists are defined as physicians who have performed 100 or more endoscopic treatments for esophageal and gastric cancers and independently conduct endoscopic therapy.
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 with a current diagnosis of esophageal cancer or gastric cancer (including adenoma) who are scheduled to undergo diagnostic esophagogastroduodenoscopy at Jikei University Kashiwa Hospital or Jikei University Katsushika Medical Center.
Patients who have received a full explanation of the study, have demonstrated sufficient understanding, and have provided written informed consent of their own free will to participate in the study.
Key exclusion criteria
Patients who are minors (under 20 years of age).
Patients who have received chemotherapy for a malignant tumor within the past 12 months.
Patients in whom biopsy cannot be performed at the time of endoscopy (e.g., due to ongoing antithrombotic therapy).
Patients in whom iodine staining of the esophagus cannot be performed due to allergy or other contraindications.
Patients who are deemed inappropriate for enrollment in this study by the treating physician or examining endoscopist for any other reason.
Target sample size
138
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
TEL
+81-3-3433-1111
kaz_sum@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Jumpei |
| Middle name | |
| Last name | Yamamoto |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
277-8567
Address
163-1, Kashiwashita, Kashiwa-shi, Chiba, Japan
TEL
+81-4-7164-1111
Homepage URL
juno178.7328@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel
+81-3-3433-1111
rinri@jikei.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
| 2026 | Year | 03 | 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
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069727
