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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043838
Receipt No. R000050031
Scientific Title Evaluation of color difference and visibility of early gastric cancer in Texture and Color Enhancement Imaging
Date of disclosure of the study information 2021/04/05
Last modified on 2021/04/05

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Basic information
Public title Evaluation of color difference and visibility of early gastric cancer in Texture and Color Enhancement Imaging
Acronym TXI EGC
Scientific Title Evaluation of color difference and visibility of early gastric cancer in Texture and Color Enhancement Imaging
Scientific Title:Acronym TXI EGC
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This pilot study aimed to compare the color difference and visibility of EGC between WLI and TXI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mean color difference of the area between peripheral and inner points, and mean color change per lesion in WLI, TXI mode 1, and TXI mode 2.
The visibility score of EGC images of TXI mode 1 and 2 compared with WLI.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients undergoing ESD
Key exclusion criteria lack of suitable endoscopic image
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Seiichiro
Middle name Seiichiro
Last name Abe
Organization National Cancer Center Hospital
Division name Endoscopy Division
Zip code 1040045
Address 5-1-1, Tsukiji, Chuo-ku,
TEL 0335422511
Email seabe@ncc.go.jp

Public contact
Name of contact person
1st name Seiichiro Abe
Middle name
Last name Abe
Organization National Cancer Center Hospital
Division name Endoscopy Division
Zip code 1040045
Address 5-1-1, Tsukiji, Chuo-ku,
TEL 0335422511
Homepage URL
Email seabe@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization NA
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 National Cancer Center Hospital
Address 5-1-1, Tsukiji, Chuo-ku,
Tel 0335422511
Email irst@ncc.go.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
2021 Year 04 Month 05 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 20
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 No longer recruiting
Date of protocol fixation
2020 Year 08 Month 03 Day
Date of IRB
2020 Year 09 Month 07 Day
Anticipated trial start date
2020 Year 09 Month 25 Day
Last follow-up date
2020 Year 10 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study using endoscopic still images

Management information
Registered date
2021 Year 04 Month 05 Day
Last modified on
2021 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050031

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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