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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005005
Receipt No. 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

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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
Email 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
Email kenshin@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005946

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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