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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042405
Receipt No. 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 2021/03/07

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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
Email 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
Email space-rendez-vous@sings.jp

Sponsor
Institute Kochi Red Cross Hospital
Institute
Department

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
Email 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
2022 Year 03 Month 31 Day
Date of closure to data entry
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
2021 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048393

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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