UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective cohort study on the risk prediction of metachronous gastric cancer after endoscopic resection by DNA methylation markers
Acronym	Risk prediction of metachronous gastric cancer after endoscopic resection
Scientific Title	Multicenter prospective cohort study on the risk prediction of metachronous gastric cancer after endoscopic resection by DNA methylation markers
Scientific Title:Acronym	Risk prediction of metachronous gastric cancer after endoscopic resection
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to clarify, by multicenter prospective cohort study, whether DNA methylation levels in noncancerous gastric mucosa taken by biopsy are useful for the prediction of the risk of metachronous gastric cancer after endoscopic resection.
Basic objectives2	Others
Basic objectives -Others	Hazard ratio of developing metachronous gastric cancer
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence rate of metachronous gastric cancer
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
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Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who planned to have, or had undergone, endoscopic resection for primary gastric cancer.
Key exclusion criteria	1. Patients suffering from an untreated cancer 2. Active infection (Tempereture >=38 centigrade) 3. Active gastrointestinal bleeding 4. Bleeding tendency or coagulopathy 5. Patients considered unsuitable for endoscopy
Target sample size	800

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 Ichiro Middle name Last name Oda
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	ioda@ncc.go.jp

Sponsor
Institute	Division of Epigenomics, National Cancer Center Research Institute, Tokyo, Japan
Institute
Department

Funding Source
Organization	The Ministry of Health, Labour and Welfare and National Cancer Center
Organization
Division
Category of Funding Organization	Japanese Governmental office
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）、和歌山県立医科大学附属病院（和歌山県）、東京大学医学部附属病院（東京都）、国立国際医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	http://gut.bmj.com/content/64/3/388.long
Number of participants that the trial has enrolled	825
Results	Among 826 patients enrolled, 782 patients had at least one follow-up, with a median follow-up of 2.97 years. Authentic metachronous gastric cancers developed in 66 patients. The highest quartile of the miR-124a-3 methylation levelhad a significant univariate HR (95% CI) (2.17 (1.07 to 4.41); p=0.032) and a multivariate-adjusted HR (2.30(1.03 to 5.10); p=0.042) of developing authentic metachronous gastric cancers. Similar trends were seen for EMX1 and NKX6-1.
Results date posted	2019 Year 09 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2008 Year 01 Month 11 Day
Date of IRB	2008 Year 04 Month 11 Day
Anticipated trial start date	2008 Year 04 Month 17 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Patients with early gastric cancer, aged 40-80 years, who planned to have, or had undergone,ER, were enrolled at least 6 months after Helicobacter pylori infection discontinued. Methylation levels of three preselected genes (miR-124a-3, EMX1 and NKX6-1) were measured by quantitative methylation-specific PCR. Patients were followed up annually by endoscopy, and the primary endpoint was defined as detection of a metachronous gastric cancer. Authentic metachronous gastric cancers were defined as cancers excluding those detected within 1 year after the enrolment.

Management information
Registered date	2015 Year 03 Month 21 Day
Last modified on	2019 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019021

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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