UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043838 |
|---|---|
| Receipt number | 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 | 2024/04/07 18:25:11 |
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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 | none |
| Last name | Abe |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku,
TEL
0335422511
seabe@ncc.go.jp
Public contact
Name of contact person
| 1st name | Seiichiro Abe |
| Middle name | none |
| 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
seabe@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
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
https://onlinelibrary.wiley.com/doi/10.1002/deo2.46
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/deo2.46
Number of participants that the trial has enrolled
20
Results
https://onlinelibrary.wiley.com/doi/10.1002/deo2.46
Results date posted
| 2024 | Year | 04 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://onlinelibrary.wiley.com/doi/10.1002/deo2.46
Participant flow
https://onlinelibrary.wiley.com/doi/10.1002/deo2.46
Adverse events
none
Outcome measures
https://onlinelibrary.wiley.com/doi/10.1002/deo2.46
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050031
