UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045989 |
|---|---|
| Receipt number | R000052496 |
| Scientific Title | Prevalence of intestinal metaplasia in the Helicobacter pylori-naive stomach |
| Date of disclosure of the study information | 2021/11/08 |
| Last modified on | 2021/11/05 16:38:50 |
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Basic information
Public title
Prevalence of intestinal metaplasia in the Helicobacter pylori-naive stomach
Acronym
Prevalence of intestinal metaplasia in the Helicobacter pylori-naive stomach
Scientific Title
Prevalence of intestinal metaplasia in the Helicobacter pylori-naive stomach
Scientific Title:Acronym
Prevalence of intestinal metaplasia in the Helicobacter pylori-naive stomach
Region
| Japan |
Condition
Condition
Intestinal metaplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the prevalence, location, gross configuration and patient characteristics of intestinal metaplasia in the Helicobacter pylori-naive stomach.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of intestinal metaplasia in gastritis-like lesion in the Helicobacter pylori-naive stomach.
Key secondary outcomes
1) The incidence of cancer in gastritis-like lesion in the Helicobacter pylori-naive stomach.
2) The difference in clinicopathological characteristics between patients with and without gastric 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Negative for Helicobacter pylori infection.
2) Non-gastric mucosal atrophy on endoscopy.
3) Sporadic or regional mucosal abnormality related to gastritis. Then, biopsy is performed to rule out gastric cancer.
4) Over 20 year old.
5) Informed consent about this research has been obtained with participants in writing form.
Key exclusion criteria
1) Difficult case to evaluate pathological features.
2) Patients with high risk of bleeding.
3) Inappropriate case for this research.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Shibagaki |
Organization
Shimane University Hospital
Division name
Gastroenterology
Zip code
693-8501
Address
89-1 Enya, Izumo, Japan
TEL
0853-20-2190
kotaro@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Watanabe |
Organization
Shimane University Hospital
Division name
Gastroenterology
Zip code
693-8501
Address
89-1 Enya, Izumo, Japan
TEL
0853-20-2190
Homepage URL
maki-w@med.shimane-u.ac.jp
Sponsor or person
Institute
Gastroenterology, Faculty of Medicine, Shimane University
Institute
Department
Personal name
Funding Source
Organization
None
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
Shimane University Hospital
Address
89-1 Enya, Izumo, Japan
Tel
0853-20-2190
kotaro@med.shimane-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
| 2021 | Year | 11 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is multicenter prospective study to investigate the prevalence, location, gross configuration and patient characteristics of intestinal metaplasia in the Helicobacter pylori-naive stomach.
Management information
Registered date
| 2021 | Year | 11 | Month | 05 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052496
