UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058992 |
|---|---|
| Receipt number | R000067431 |
| Scientific Title | Histopathological study of white opaque substance in gastric intestinal epithelial metaplasia visualized by magnifying endoscopy with NBI |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/09/04 17:27:51 |
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Basic information
Public title
Histopathological study of white opaque substance in gastric intestinal epithelial metaplasia visualized by magnifying endoscopy with NBI
Acronym
Histopathological study of white opaque substance in gastric intestinal epithelial metaplasia visualized by magnifying endoscopy with NBI
Scientific Title
Histopathological study of white opaque substance in gastric intestinal epithelial metaplasia visualized by magnifying endoscopy with NBI
Scientific Title:Acronym
GIM-Adipophilin study
Region
| Japan |
Condition
Condition
chronic gastritis, gastric intestinal metaplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Histopathological verification of whether WOS observed in gastric intestinal epithelialisation is a fat droplet or not.
Basic objectives2
Others
Basic objectives -Others
To clarify the factors that cause the high frequency of WOS in incomplete intestinal metaplasia
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of adipophilin expression frequency in gastric intestinal metaplasia with and without WOS.
Key secondary outcomes
Comparison of the Presence, Localization, and Density of Adipophilin in Complete and Incomplete Intestinal metaplasia.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adipophiln staining will be performed on all pathology specimens of gastric intestinal metaplasia collected in the previous study, "Magnifying endoscopy with narrow-band imaging for the subtype of gastric intestinal metaplasia" (Approval No.: C20-06-004, UMINCTR 000041119).
Key exclusion criteria
Biopsy specimens that are too small to prepare additional immunohistochemical stained specimens
Target sample size
98
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, Zokyumyoin, Chikushino City, Fukuoka
TEL
0929211011
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, Zokyumyoin, Chikushino City, Fukuoka
TEL
0929211011
Homepage URL
t.kanemitsu93@gmail.com
Sponsor or person
Institute
Fukuoka University Chikushi Hospital, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi 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
The ethics committee of Fukuoka University
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 05 | 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 | 02 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
no related information
Management information
Registered date
| 2025 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067431
