UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective cohort study to identify high-risk group for primary gastric cancer using DNA methylation levels in normal-appearing gastric tissues in healthy people after Helicobacter pylori eradication
Acronym	Risk prediction of gastric cancer after H. pylori eradication
Scientific Title	Multicenter prospective cohort study to identify high-risk group for primary gastric cancer using DNA methylation levels in normal-appearing gastric tissues in healthy people after Helicobacter pylori eradication
Scientific Title:Acronym	Risk prediction of gastric cancer after H. pylori eradication
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate that assessment of DNA methylation levels in gastric mucosae can identify high-risk group for primary gastric cancer and enable risk stratification of healthy people after H. pylori eradication.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	disease-free survival
Key secondary outcomes	- Incidence of primary gastric cancer and metachronous gastric cancer - Accuracy of prediction by DNA methylation markers (positive predictive value, negative predictive value, etc)

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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age of 20 to 75 years old at the time of enrollment. 2) ECOG PS of 0 or 1. 3) Past infection with H.pylori confirmed by urea breath test, rapid urease test, serum H.pylori IgG Ab, microscopic analysis of a gastric biopsy specimen, cultivation, a urine antibody test, or stool antigen test. 4) Eradicated for H. pylori in or after February 2013. 5) Chronic gastritis with an open-type atrophic change at the time of eradication. 6) Successful eradication of H.pylori confirmed by urea breath test or stool antigen test. 7) Written informed consent.
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies, except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Past history of gastrectomy, endoscopic treatment of a gastric tumor, and reconstructive surgery with a stomach tube for an esophageal cancer. 3) Past history of receiving chemotherapy (including endocrinotherapy) or radiation therapy against any other malignancies. 4) Suspicious gastric tumor by endoscopy or gastric biopsy at the time of eradication. 5) Psychosis. 6) Systemic steroid medication. 7) Individuals with two or more kinds of antiplatelet medications, with anticoagulant medication, or with coagulopathy. 8) Active gastrointestinal bleeding. 9) Individuals considered unsuitable for biopsy by an endoscopist. 10) Individuals with hereditary gastrointestinal tumors, including familial adenomatous polyposis (FAP), Lynch syndrome or Hereditary non-polyposis colorectal cancer (HNPCC), Peutz-Jeghers syndrome, Cowden syndrome, and Hereditary diffuse gastric cancer.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Toshikazu Middle name Last name Ushijima
Organization	National Cancer Center Research Institute, Tokyo, Japan
Division name	Division of Epigenomics
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL	+81-3-3542-2511
Email	tushijim@ncc.go.jp

Public contact
Name of contact person	1st name Seiichiro Middle name Last name Abe
Organization	National Cancer Center Hospital, Tokyo, Japan
Division name	Endoscopy Division
Zip code	104-0045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL	+81-3-3542-2511
Homepage URL
Email	seabe@ncc.go.jp

Sponsor
Institute	National Cancer Center Research Institute, Tokyo, Japan
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, National Cancer Center Research Institute
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel	03-3542-2511
Email	irst@ml.res.ncc.go.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中央病院(東京都）、湘南鎌倉総合病院（神奈川県）、日本橋大三クリニック（東京都）、長崎県壱岐病院（長崎県）、さっぽろ白石内科消化器クリニック（北海道）、和歌山県立医科大学附属病院（和歌山県）、和歌山ろうさい病院（和歌山県）、橋本市民病院（和歌山県）、有田市立病院（和歌山県）、国保日高総合病院（和歌山県）、新宮市立医療センター（和歌山県）、済生会有田病院（和歌山県）、済生会和歌山病院（和歌山県）、向陽病院（和歌山県）、中谷病院（和歌山県）、上山病院（和歌山県）、名手病院（和歌山県）、北出病院（和歌山県）、NSメディカル・ヘルスケアサービス（和歌山県）、なかた消化器・内科クリニック（和歌山県）、上田消化器・内科クリニック（和歌山県）、国保野上厚生病院（和歌山県）、中江病院（和歌山県）、富山大学附属病院（富山県）、富山赤十字病院（富山県）、富山県済生会富山病院（富山県）、高岡市民病院（富山県）、厚生連高岡病院（富山県）、上越総合病院（新潟県）、東京大学医学部附属病院（東京都）、東芝病院（東京都）、亀田総合病院（千葉県）、日本医科大学付属病院（東京都）、虎の門病院（東京都）、一志胃腸科クリニック（東京都）、大分大学医学部附属病院（大分県）、有田胃腸病院（大分県）、大分県厚生連鶴見病院（大分県）、あべ胃腸内視鏡クリニック（大分県）、浜松医科大学医学部附属病院（静岡県）、浜松医療センター（静岡県）、JA静岡厚生連遠州病院（静岡県）、磐田市立総合病院（静岡県）、広島大学病院（広島県）、国立病院機構呉医療センター（広島県）、国立病院機構広島西医療センター（広島県）、県立広島病院（広島県）、県立安芸津病院（広島県）、広島市立安佐市民病院（広島県）、市立三次中央病院（広島県）、広島記念病院（広島県）、呉共済病院（広島県）、済生会広島病院（広島県）、中国労災病院（広島県）、広島赤十字･原爆病院（広島県）、庄原赤十字病院（広島県）、広島総合病院（広島県）、尾道総合病院（広島県）、吉田総合病院（広島県）、JR広島病院（広島県）、三菱三原病院（広島県）、マツダ病院（広島県）、呉市医師会病院（広島県）、安芸太田病院（広島県）、本郷中央病院（広島県）、河村内科消化器クリニック（広島県）、益田内科胃腸科医院（広島県）、滋賀医科大学附属病院（滋賀県）、JCHO滋賀病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 24 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	1880
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	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 10 Day
Date of IRB	2015 Year 03 Month 24 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2024 Year 09 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Healthy people who received H. pylori eradication in or after Feb. 2013 are enrolled. Biopsy samples are taken by endoscopy from 2 fixed points in the antrum and gastric body (the lesser curvature) for DNA methylation analysis at least 10 months after successful H. pylori eradication therapy. Methylation levels of preselected genes are measured by quantitative methylation-specific PCR. Blinded to methylation information, people are followed up annually by endoscopy for 5 years to detect primary gastric cancers. An association between DNA methylation levels and the incidence of primary gastric cancer is analyzed.

Management information
Registered date	2015 Year 03 Month 24 Day
Last modified on	2021 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019470

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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