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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039528
Receipt No. 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 2020/02/19

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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
Email 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
Email k-niimi@umin.ac.jp

Sponsor
Institute Graduate School of Medicine, The University of Tokyo, Center for Epidemiology and Preventive Medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 06 Day
Date of IRB
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
2020 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045051

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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