UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060761 |
|---|---|
| Receipt number | R000067471 |
| Scientific Title | Relationship Between White Opaque Substance Observed by Magnifying NBI Endoscopy Under Intragastric Neutralization and Gastric Cancer Risk: A Pilot Study |
| Date of disclosure of the study information | 2026/02/26 |
| Last modified on | 2026/02/26 17:55:48 |
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Basic information
Public title
Relationship Between White Opaque Substance Observed by Magnifying NBI Endoscopy Under Intragastric Neutralization and Gastric Cancer Risk: A Pilot Study
Acronym
Relationship Between White Opaque Substance Observed by Magnifying NBI Endoscopy Under Intragastric Neutralization and Gastric Cancer Risk: A Pilot Study
Scientific Title
Relationship Between White Opaque Substance Observed by Magnifying NBI Endoscopy Under Intragastric Neutralization and Gastric Cancer Risk: A Pilot Study
Scientific Title:Acronym
PPI-WOS-GIM study
Region
| Japan |
Condition
Condition
Chronic gastritis, gastric intestinal metaplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between WOS and gastric cancer under gastric acid-neutralized conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of WOS scores between patients with and without gastric cancer.
Key secondary outcomes
1. Association between the development of gastric cancer and each risk factor (WOS score, EGGIM score, degree of OLGIM classification, degree of gastric mucosal atrophy, alcohol consumption, smoking, family history of gastric cancer, and H. pylori infection status).
2. Frequency of synchronous and metachronous multiple gastric cancers according to WOS score.
3. Comparison of LBC scores between patients with and without gastric cancer.
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
Inclusion criteria for the gastric cancer group
1. Patients with a histologically confirmed diagnosis of gastric cancer based on biopsy.
2. Patients who require upper gastrointestinal endoscopy at Fukuoka University Chikushi Hospital for the treatment or further evaluation of gastric cancer.
3. Patients aged 20 years or older.
4. Patients who have been receiving any proton pump inhibitor for at least 1 week.
5. Patients who have provided written informed consent for study participation.
Inclusion criteria for the non-gastric cancer group
1. Patients who require upper gastrointestinal endoscopy at Fukuoka University Chikushi Hospital for any reason.
2. Patients with no prior history of gastric cancer.
3. Patients aged 20 years or older.
4. Patients who have been receiving any proton pump inhibitor for at least 1 week.
5. Patients who have provided written informed consent for study participation.
Key exclusion criteria
1. Patients in whom adequate observation of the gastric mucosa is difficult.
2. Patients with a history of gastrectomy.
3. Patients at high risk of bleeding from biopsy due to underlying conditions such as hepatic dysfunction, renal dysfunction, or coagulation disorders.
4. Patients in whom biopsy cannot be performed due to the use of anticoagulant or antiplatelet agents.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka
TEL
0570-02-7777
t.kanemitsu93@gmail.com
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kanemitsu |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka
TEL
0570-02-7777
Homepage URL
t.kanemitsu93@gmail.com
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
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
Fukuoka University Ethics Review Board
Address
7-45-1 Nanakuma, Jonan Ward, Fukuoka City, Fukuoka
Tel
092-801-1011
fumed-ethics@fukuoka-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
福岡大学筑紫病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067471
