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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Gastric cancer | |
Classification by specialty |
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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 | |
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Stratification | |
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Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
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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 |
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Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Research Institute,
Tokyo, Japan |
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Division name | Division of Epigenomics | ||||||
Zip code | 104-0045 | ||||||
Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan | ||||||
TEL | +81-3-3542-2511 | ||||||
tushijim@ncc.go.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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. |
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Results date posted |
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Baseline Characteristics | |||||||
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Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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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 | |||||||
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Last modified on |
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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 | |
Registered date | File name |