UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042405 |
|---|---|
| Receipt number | R000048393 |
| Scientific Title | Comparison of the accuracy of TXI (Texture and Color Enhancement Imaging) mode 1 and TXI mode 2 in gastric epithelial tumors of upper gastrointestinal endoscopy |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2023/05/15 23:00:31 |
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Basic information
Public title
Comparison of the accuracy of TXI (Texture and Color Enhancement Imaging) mode 1 and TXI mode 2 in gastric epithelial tumors of upper gastrointestinal endoscopy
Acronym
Evaluation of the accuracy by TXI mode in upper gastrointestinal endoscopy
Scientific Title
Comparison of the accuracy of TXI (Texture and Color Enhancement Imaging) mode 1 and TXI mode 2 in gastric epithelial tumors of upper gastrointestinal endoscopy
Scientific Title:Acronym
Evaluation of the accuracy by TXI mode in upper gastrointestinal endoscopy
Region
| Japan |
Condition
Condition
gastric cancer, gastric adenoma, malignant lymphoma, gastric polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the difference between TXI mode1 and TXI mode2
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of accuracy of TXI mode1 and TXI mode2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients before and after receiving Helicobacter pylori eradication treatment
Patients with a B rating or higher on the gastric cancer risk stratification test
Patients with a history of gastric cancer treatment
Key exclusion criteria
Patients who don't agree this study
Patients who cannot be taken biopsy due to comorbidities
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Iwasaki |
Organization
Kochi Red Cross hospital
Division name
Gastroenterology
Zip code
780-8562
Address
1-4-63-11 Hataminamichou
TEL
0888221201
space-rendez-vous@sings.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Iwasaki |
Organization
Kochi Red Cross Hospital
Division name
Gastroenterology
Zip code
780-8562
Address
1-4-63-11 Hataminamichou
TEL
0888221201
Homepage URL
space-rendez-vous@sings.jp
Sponsor or person
Institute
Kochi Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Kochi Red Cross Hospital
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
Kochi Red Cross Hospital
Address
1-4-63-11 Hataminamichou
Tel
0888221201
space-rendez-vous@sings.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 | 01 | Month | 01 | 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
| 2020 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of detectability of TXI mode1 of mode2
Management information
Registered date
| 2020 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048393
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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