UMIN-CTR Clinical Trial

Basic information
Public title	Study of the superiority of image-enhanced endoscopy in the detection of neoplastic lesions using eye-tracking
Acronym	Study of the superiority of image-enhanced endoscopy in the detection of neoplastic lesions using eye-tracking
Scientific Title	Study of the superiority of image-enhanced endoscopy in the detection of neoplastic lesions using eye-tracking
Scientific Title:Acronym	Study of the superiority of image-enhanced endoscopy in the detection of neoplastic lesions using eye-tracking
Region	Japan

Condition
Condition	Gastric cancer, esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the advantage of LCI in epithelial neoplasia detection using eye-tracking.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity for the diagnosis of epithelial neoplasia in WLI and LCI.
Key secondary outcomes	1. detection time 2. specificity, PPV, NPV 3. visual gaze pattern 4. correlation between color difference and sensitivity 5. sensitivity according to endoscopic experience

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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Doctors without ophthalmic disease, severe myopia or narrowing of the visual field. Doctors who have obtained written consent to participate in this study
Key exclusion criteria	Doctors who could not obtain eye-tracking data Doctors who are judged by the principal investigator to be inappropriate as research subjects
Target sample size	9

Research contact person
Name of lead principal investigator	1st name SHOKO Middle name Last name ONO
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Zip code	060-8648
Address	W5,N14, Kita-ku, Sapporo
TEL	0117161161
Email	onosho@med.hokudai.ac.jp

Public contact
Name of contact person	1st name SHOKO Middle name Last name ONO
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Zip code	060-8648
Address	W5,N14, Kita-ku, Sapporo
TEL	0117161161
Homepage URL
Email	onosho@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address	W5,N14, Kita-ku, Sapporo
Tel	011-706-7636
Email	crjimu@huhp.hokudai.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	2022 Year 06 Month 04 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	9
Results	LCI enables epithelial lesion detection that cannot be detected with WLI, and a clinical additive value for nonexperts was determined.
Results date posted	2022 Year 09 Month 25 Day
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	Completed
Date of protocol fixation	2021 Year 10 Month 18 Day
Date of IRB	2021 Year 10 Month 27 Day
Anticipated trial start date	2021 Year 10 Month 27 Day
Last follow-up date	2022 Year 06 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 09 Month 30 Day

Other
Other related information	Diagnostic accuracy of epithelial tumors is evaluated in WLI and LCI using eye-tracking.

Management information
Registered date	2022 Year 06 Month 04 Day
Last modified on	2022 Year 09 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054659