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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013761
Receipt No. R000016049
Scientific Title Effects of chronic Helicobacter pylori infection upon systemic organs
Date of disclosure of the study information 2014/04/19
Last modified on 2019/05/08

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Basic information
Public title Effects of chronic Helicobacter pylori infection upon systemic organs
Acronym Effects of H. pylori on systemic organs
Scientific Title Effects of chronic Helicobacter pylori infection upon systemic organs
Scientific Title:Acronym Effects of H. pylori on systemic organs
Region
Japan

Condition
Condition Disorders of systemic organs
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Hematology and clinical oncology Laboratory medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our aim is to elucidate various effects of chronic Helicobacter pylori infection upon various systemic disoders, using the large-scale data of healthy subjects.
Basic objectives2 Others
Basic objectives -Others etiological influences
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of various disorders of systemic organs
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The study population was the subjects who received medical checkup at Kameda Medical Center Makuhari (Chiba-shi, Chiba, Japan) in 2010, approved their entry to our study, were not less than 20 years old, and answered to the questionnaire.
Key exclusion criteria age less than 20 years and insufficient answers to the questionnaire
Target sample size 21000

Research contact person
Name of lead principal investigator
1st name Nobutake
Middle name
Last name Yamamichi
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Gastroenterology
Zip code 113-8655
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL +81-3-3815-5411
Email nyamamic-tky@umin.ac.jp

Public contact
Name of contact person
1st name Nobutake
Middle name
Last name Yamamichi
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Gastroenterology
Zip code 113-8655
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL +81-3-3815-5411
Homepage URL
Email nyamamic-tky@umin.ac.jp

Sponsor
Institute Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization a grant from Chiyoda Mutual Life Foundation, the Shimabara Science Promotion Foundation, St. Luke's Life Science Institute, and the Daiwa Security Health Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee / Human Genome, Gene Analysis Research Ethics Committee of the Faculty of Medicine and Graduate School of Medicine of the Univ of Tokyo, and the Univ of Tokyo hospital
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel 0338155411
Email ethics@m.u-tokyo.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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 20773
Results
Takeuchi C, Yamamichi N, et al. 
Gastric Cancer. 2017; 20(2):314-321.

Yamamichi N, et al. 
PLoS One. 2015; 10(4):e0123688. 

Takahashi Y, Yamamichi N, et al. 
J Gastroenterol. 2014; 49(5):882-9.

Yamamichi N, Hirano C, et al. 
PLoS One. 2014; 9(10):e111359.

Yamamichi N, et al. 
PLoS One. 2014; 9(2):e88277.

Minatsuki C, Yamamichi N, , et al. 
PLoS One. 2013; 8(7):e69891.

Shimamoto T, Yamamichi N, , et al. 
PLoS One. 2013; 8(6):e65996.

Yamamichi N, Mochizuki S, , et al. 
BMC Med. 2012; 10:45.
Results date posted
2019 Year 05 Month 08 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
2009 Year 12 Month 22 Day
Date of IRB
2010 Year 01 Month 04 Day
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2025 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The data of all the study participants are continually accumulated.

Management information
Registered date
2014 Year 04 Month 18 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016049

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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