UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047944 |
|---|---|
| Receipt number | R000054659 |
| Scientific Title | Study of the superiority of image-enhanced endoscopy in the detection of neoplastic lesions using eye-tracking |
| Date of disclosure of the study information | 2022/06/04 |
| Last modified on | 2022/09/25 15:38:28 |
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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
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
onosho@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054659
