UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041119 |
|---|---|
| Receipt number | R000046934 |
| Scientific Title | The evaluation of the relationship between microsurface pattern of gastric intestinal metaplasia visualized by magnifying endoscopy with narrow-band imaging and subtypes of intestinal metaplasia |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2022/01/21 09:56:36 |
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Basic information
Public title
The evaluation of the relationship between microsurface pattern of gastric intestinal metaplasia visualized by magnifying endoscopy with narrow-band imaging and subtypes of intestinal metaplasia
Acronym
NBI IM study
Scientific Title
The evaluation of the relationship between microsurface pattern of gastric intestinal metaplasia visualized by magnifying endoscopy with narrow-band imaging and subtypes of intestinal metaplasia
Scientific Title:Acronym
NBI IM 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 clarify the frequency and pathological features of foveola-type intestinal metaplasia and groove-type intestinal metaplasia visualized by M-NBI in the stomach.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The differences in the ratio of complete intestinal metaplasia and incomplete intestinal metaplasia according to micro-mucosal pattern (foveola type, groove type).
Key secondary outcomes
1. The difference in the ratio of micro-mucosal pattern (foveola type, groove type) according to the localization of intestinal metaplasia.
2. The difference in the macroscopic type in white light imaging according to micro-mucosal pattern (foveola type, groove type).
3. The difference in color in white light imaging according to micro-mucosal pattern (foveola type, groove type).
4. The frequency of LBC by micro-mucosal pattern (foveola type, groove type).
5. The frequency of WOS by micro-mucosal pattern (foveola type, groove type).
6. The difference in the frequency of gastric epithelial tumors (including a history) with and without endoscopic intestinal metaplasia.
7. The Relationship between micro-mucosal pattern (foveola type, groove type) and H. pylori infection status (currently infected or already infected).
8. The difference in the extent of atrophic gastritis by micro-mucosal pattern (foveola type, groove type).
9. Intra-observer concordance rate and inter-observer concordance rate of micro-mucosal pattern (foveola type, groove type).
10. The differences in the ratio of complete intestinal metaplasia and incomplete intestinal metaplasia according to markers of intestinal metaplasia (LBC, WOS, MTB).
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
1. Patients who give their informed consent to be involved in this study before the endoscopic examination.
Key exclusion criteria
1. Patients who are receiving warfarin or any anticoagulant treatment;
2. Patients who underwent gastrectomy
3. Patients with severe underlying disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Endoscopy
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino City, Fukuoka
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kanemitsu |
Organization
Fukuoka University Chikushi Hospital
Division name
Endoscopy
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino City, Fukuoka
TEL
092-921-1011
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, Department of Gastroenterology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka International Cancer Institute, Department of Gastrointestinal Oncology
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
福岡大学筑紫病院（福岡）、大阪国際がんセンター（大阪）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 20 | 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
150
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
no related information
Management information
Registered date
| 2020 | Year | 07 | Month | 15 | Day |
Last modified on
| 2022 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046934
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