UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005005 |
|---|---|
| Receipt number | R000005946 |
| Scientific Title | The association between lifestyle factors and DNA methylation levels in gastric mucosa of participants in cancer screening |
| Date of disclosure of the study information | 2011/02/02 |
| Last modified on | 2015/11/19 15:26:47 |
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Basic information
Public title
The association between lifestyle factors and DNA methylation levels in gastric mucosa of participants in cancer screening
Acronym
Lifestyle factors and DNA methylation levels in gastric mucosa
Scientific Title
The association between lifestyle factors and DNA methylation levels in gastric mucosa of participants in cancer screening
Scientific Title:Acronym
Lifestyle factors and DNA methylation levels in gastric mucosa
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the association between lifestyle factors and DNA methylation levels in gastric mucosa
Basic objectives2
Others
Basic objectives -Others
To investigate the association with DNA methylation levels in gastric mucosa, after eradicating current Helicobacter pylori infection.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DNA methylation levels in gastric mucosa
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Treatment to eradicate Helicobacter pylori in infected participants: 7-day course of lansoprazole, clarithromycin, and amoxicillin
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Examinees who 1) underwent upper gastrointestinal endoscopy as part of the cancer screening program provided by the Research Center for Cancer Prevention and Screening of the National Cancer Center and 2) gave written informed consent to participate in the study
Key exclusion criteria
1) History of treatment for Helicobacter pylori infection, 2) use of nonsteroidal anti-inflammatory drugs during previous 30 days, 3) upper gastrointestinal endoscopy during previous 1 year, 4) >=10% weight loss during previous 3 months, 5) history of gastric cancer, 6) history of gastrectomy, antireflux procedure, or vagotomy, 7) pregnancy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Tsugane |
Organization
Research Center for Cancer Prevention and Screening, National Cancer Center
Division name
Epidemiology and Prevention Group
Zip code
Address
5-1-1 Tsukiji, Chuo-ku Tokyo
TEL
03-3542-2511
kenshin@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taichi Shimazu |
Organization
Research Center for Cancer Prevention and Screening, National Cancer Center
Division name
Epidemiology and Prevention Group
Zip code
Address
5-1-1 Tsukiji, Chuo-ku Tokyo
TEL
03-3542-2511
Homepage URL
http://epi.ncc.go.jp/mstudy/766/3706.html
kenshin@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology
IRB Contact (For public release)
Organization
Address
Tel
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
国立研究開発法人国立がん研究センター（東京）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26354778
Number of participants that the trial has enrolled
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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 02 | Day |
Last modified on
| 2015 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005946
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
