UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016864 |
|---|---|
| Receipt number | 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 | 2024/10/28 14:07:41 |
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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
Hoshi University
Division name
President
Zip code
104-0045
Address
2-4-41 Ebara Shinagawa-ku Tokyo, Japan
TEL
+81-3-5498-5746
tushijima142@hoshi.ac.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
seabe@ncc.go.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
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, Hoshi University
Address
2-4-41 Ebara Shinagawa-ku Tokyo, Japan
Tel
03-3786-1011
y-hashiguchi@hoshi.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
星薬科大学（東京都）、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
No URL
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
Among the 826 enrolled patients, 782 patients (617, 97 and 68 patients at NCC, TYU and WMU, respectively) had at least one follow up endoscopic examination . Among the 782 patients, 81 patients (59, 10 and 12 patients in NCC, TYU and WMU, respectively) developed a metachronous gastric cancer. Among the 81 patients, 15, 29, 16 and 21 patients developed a metachronous cancer in less than 1, 1-2, 2-3 and 3 or more years after the enrolment, respectively, and 66 patients (52, 6 and 8 patients in NCC, TYU and WMU, respectively) were considered to have authentic metachronous gastric cancers. The median follow-up period was 2.97 years (2.99, 2.51 and 2.49 years in NCC, TYU and WMU, respectively). The median period for development of all the metachronous cancers after the enrolment was 1.88 years (1.92, 1.97 and 1.32 years in NCC, TYU and WMU, respectively).
Participant flow
Eligibility was assessed for 964 patients with early gastric cancer aged 40-80 years and who planned to have, or had undergone, endoscopic submucosal dissection, one of the procedures of ER, in one of three hospitals (National Cancer Center Hospital (NCC), Tokyo University Hospital (TYU) and Wakayama Medical University Hospital (WMU)) between 2008 and 2010. Patients were excluded if they had received additional gastrectomy, had cancer in other tissues, died of other diseases before a test for H. pylori infection or were receiving anticoagulant therapy and unable to suspend it, refused or had other complications. The remaining 850 patients were tested for H. pylori infection. When H. pylori infection was absent, they were enrolled at the assessment (n=388). When H. pylori infection was present (n=462), patients received eradication therapy and were enrolled at least 6 months after establishment of successful H. pylori eradication (n=438) . A total of 826 patients were enrolled and at the time of enrolment, biopsy samples were taken from a fixed point in the antrum (the lesser curvature at 2 cm from the pyloric ring) for DNA methylation analysis. Written informed consent was obtained from all the patients and the study was approved by the institutional review boards at each hospital.
Adverse events
There was no adverse event.
Outcome measures
Outcome measures is the hazard ratio and 95% confidence interval of quartiles4 (Q4) with the highest methylation level of three gastric cancer risk marker genes which were preselected in the previous cross-sectional studies compared to quartiles1 (Q1) with the lowest.
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,endoscopic submucosal dissection (ESD), 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
| 2024 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019021
