UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039528 |
|---|---|
| Receipt number | R000045051 |
| Scientific Title | An epigenetic analysis and gene expression profiling on autoimmune gastritis; a multicenter cross-sectional and prospective study |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2022/03/17 13:23:16 |
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Basic information
Public title
An epigenetic analysis and gene expression profiling on autoimmune gastritis; a multicenter cross-sectional and prospective study
Acronym
An epigenetic analysis and gene expression profiling on autoimmune gastritis
Scientific Title
An epigenetic analysis and gene expression profiling on autoimmune gastritis; a multicenter cross-sectional and prospective study
Scientific Title:Acronym
An epigenetic analysis and gene expression profiling on autoimmune gastritis
Region
| Japan |
Condition
Condition
autoimmune gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1) To clarify differences in molecular morphology between AIG and HP gastritis and to clarify the mechanism through which malignant tumors develop from chronic inflammation in AIG
Basic objectives2
Others
Basic objectives -Others
2) To contribute to worldwide research on AIG by registering our genome-wide methylation and comprehensive gene expression information on a public database
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene expression profiling and epigenetic analysis
Key secondary outcomes
Statistical analysis associated with the risk of neoplasm emergence
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) Case with confirmed diagnosis of AIG
2) Case with confirmed diagnosis of active HP infection
3) Case without chronic gastritis by endoscopy and inapplicable to 1),2)
Key exclusion criteria
-Cases with medical history of H. pylori eradication treatment
-Cases with regular use of proton pomp inhibitor (PPI) / potassium-competitive acid blocker (P- CAB)
-Cases with medical history of surgical operation of the upper digestive tract
-Cases with medical history of malignant disease (last 5 years, with the exception of intramucosal cancer cured by local treatment)
-Patients with hereditary gastrointestinal tumor diseases (familial adenomatous polyposis, Lynch syndrome, hereditary nonpolyposis colorectal cancer, Peutz-Jeghers syndrome, Cowden syndrome, hereditary diffuse gastric cancer etc.)
-Cases with use of 2 or more antiplatelet drugs or anticoagulants, or with coagulation abnormalities
-Cases with regular use of steroids
-Minor/elderly person/handicapped person who require special consideration
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobutake |
| Middle name | |
| Last name | Yamamichi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Center for Epidemiology and Preventive Medicine
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
nyamamic-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Niimi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Center for Epidemiology and Preventive Medicine
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
k-niimi@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo, Center for Epidemiology and Preventive Medicine
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, The University of Tokyo, Center for Epidemiology and Preventive Medicine
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
Graduate School of Medicine, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3815-5411
nyamamic-tky@umin.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
国立がん研究センター研究所・エピゲノム解析分野(東京都) National Cancer Center Research Institute, Division of Epigenomics
岡山大学バイオバンク(岡山県) Okayama University Hospital, Biobank
JCHO滋賀病院・総合診療科(滋賀県) JCHO Shiga Hospital, General medical department
奈良県立医科大学・消化器/内分泌代謝内科(奈良県) Nara Medical University Hospital, Gastroenterology / Metabolism and endocrinology
浜松医科大学・臨床研究管理センター(静岡県) Hamamatsu University Hospital, Center for Clinical research
徳島県総合健診センター(徳島県) Tokushima health examination center
四谷メディカルキューブ・消化器内科(東京都) Yotsuya Medical Cube, Gastroenterology
湘南鎌倉総合病院(神奈川県) Shonan Kamakura General Hospital
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 01 | 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
| 2019 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gene expression profiling and epigenetic analysis
Management information
Registered date
| 2020 | Year | 02 | Month | 18 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045051
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