UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059288 |
|---|---|
| Receipt number | R000067815 |
| Scientific Title | The Impact of Sex Differences on the Pathophysiology of Autoimmune Gastritis |
| Date of disclosure of the study information | 2025/10/04 |
| Last modified on | 2025/10/04 10:35:23 |
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Basic information
Public title
The Impact of Sex Differences on the Pathophysiology of Autoimmune Gastritis
Acronym
The Impact of Sex Differences on the Pathophysiology of Autoimmune Gastritis
Scientific Title
The Impact of Sex Differences on the Pathophysiology of Autoimmune Gastritis
Scientific Title:Acronym
The Impact of Sex Differences on the Pathophysiology of Autoimmune Gastritis
Region
| Japan |
Condition
Condition
Autoimmune Gastritis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective of this study: Autoimmune gastritis is a disease in which the gastric mucosa undergoes chronic inflammation due to autoimmune mechanisms. Although associations with various underlying diseases have been reported, the number of reported cases is small, and sufficient research has not been conducted. Furthermore, while reports indicate a higher prevalence in women, investigations into underlying diseases based on sex differences are also insufficient. The objective of this study is to compare and examine the prevalence of underlying diseases in autoimmune gastritis and the influence of sex differences on disease onset. Through this study, we aim to systematically evaluate underlying conditions, endoscopic findings, and gastric cancer incidence in autoimmune gastritis to identify useful findings for diagnosis and treatment.
Significance of this Study: The significance of this study lies in investigating underlying factors and comorbidities associated with sex differences in autoimmune gastritis.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Gender Differences in the Prevalence of Underlying Diseases in Autoimmune Gastritis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with autoimmune gastritis at Keio University Hospital between July 2012 and August 2024.
2. Patients aged 18 years or older.
Key exclusion criteria
Patients whose use of clinical data was refused
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
mori-d@keio.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
mori-d@keio.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
Tel
0333531211
med-rinri-ft_pt@adst.keio.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 | 10 | Month | 04 | 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
| 2024 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2025 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067815
