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

Email

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


Email

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

Email

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