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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016864
Receipt No. R000019021
Scientific Title Multicenter prospective cohort study on the risk prediction of metachronous gastric cancer after endoscopic resection by DNA methylation markers
Date of disclosure of the study information 2015/03/23
Last modified on 2019/09/24

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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
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
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
Participant flow
Adverse events
Outcome measures
Plan to share IPD
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
Registered date File name

Research case data
Registered date File name


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