UMIN-CTR Clinical Trial

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
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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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045051