UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046888 |
|---|---|
| Receipt number | R000053499 |
| Scientific Title | Utility of texture and color enhancement imaging (TXI) with acetic acid chromoendoscopy (ACC) for diagnosis of early gastric cancer |
| Date of disclosure of the study information | 2022/02/22 |
| Last modified on | 2024/02/14 21:21:02 |
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Basic information
Public title
Utility of texture and color enhancement imaging (TXI) with acetic acid chromoendoscopy (ACC) for diagnosis of early gastric cancer
Acronym
A study of texture and color enhancement imaging (TXI) with acetic acid chromoendoscopy (ACC) in early gastric cancer
Scientific Title
Utility of texture and color enhancement imaging (TXI) with acetic acid chromoendoscopy (ACC) for diagnosis of early gastric cancer
Scientific Title:Acronym
A study of texture and color enhancement imaging (TXI) with acetic acid chromoendoscopy (ACC) in early gastric cancer
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of TXI combined with ACC in identifying gastric neoplasm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing the efficacy of normal and TXI observation with ACC in the diagnosis of early gastric cancer
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 diagnosed with early gastric cancer or adenoma
Aged 20 years old or more
Written informed consent
Key exclusion criteria
Patients who are not received upper gastrointestinal endoscopy
Patients with severe illness
Unsuitable patient for clinical trial judged by clinicians' view
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Yamaguchi |
Organization
Toho University Omori Medical Center
Division name
Gastroenterology
Zip code
143-8541
Address
6-11-1, Omori-Nish, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
kazuhisa.yamaguchi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Yamaguchi |
Organization
Toho University Omori Medical Center
Division name
Gastroenterology
Zip code
143-8541
Address
6-11-1, Omori-Nish, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
kazuhisa.yamaguchi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University
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
Toho University Omori Medical Center
Address
6-11-1, Omori-Nish, Ota-ku, Tokyo 143-8541, Japan
Tel
0337624151
kazuhisa.yamaguchi@med.toho-u.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 | 02 | Month | 22 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
trial on going
Management information
Registered date
| 2022 | Year | 02 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053499
