UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041698
Receipt No. R000047363
Scientific Title The prevalence and transmission route of Helicobacter pylori infection by birth-year, and the genetic and environmental risk factors for Helicobacter pylori-related disease in Japanese
Date of disclosure of the study information 2020/09/06
Last modified on 2020/09/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The prevalence and transmission route of Helicobacter pylori infection by birth-year, and the genetic and environmental risk factors for Helicobacter pylori-related disease in Japanese

Acronym The prevalence and transmission route of Helicobacter pylori infection, and the genetic and environmental risk factors for Helicobacter pylori-related disease
Scientific Title The prevalence and transmission route of Helicobacter pylori infection by birth-year, and the genetic and environmental risk factors for Helicobacter pylori-related disease in Japanese

Scientific Title:Acronym The prevalence and transmission route of Helicobacter pylori infection, and the genetic and environmental risk factors for Helicobacter pylori-related disease
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Adult Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the prevalence and transmission route of Helicobacter pylori infection

To investigate the association between Helicobacter pylori -related disease and genetic, environmental factor
Basic objectives2 Others
Basic objectives -Others To investigate risk factors for Helicobacter pylori-related disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Helicobacter pylori infection rate by birth-year

The changes in biomarkers of Helicobacter pylori-related disease according to genetic and environmental factors
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japan Multi-Institutional Collaborative Cohort Study (J-MICC) Okazaki study participants and their families
Key exclusion criteria Individual with history of cancer
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Miki
Middle name
Last name Watanabe
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Public Health
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
TEL 052-853-8176
Email mwata911@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Miki
Middle name
Last name Watanabe
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Public Health
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
TEL 052-853-8177
Homepage URL
Email ncuphlab@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
Tel 052-858-7215
Email clinical_research@med.nagoya-cu.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 70-18-0007
Org. issuing International ID_1 Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 名古屋市立大学大学院医学研究科
Nagoya City University Graduate School of Medical Sciences

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 11 Day
Date of IRB
2018 Year 10 Month 23 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The subjects are randomly selected from participants of Japan Multi-Institutional Collaborative Cohort Study in Okazaki, and their family member voluntarily participate. After the participants give written informed consents, they complete the self-administered questionnaire for lifestyle, environments, and so on. At the same time, blood samples are collected. Using the serum sample, the Helicobacter pylori (H. pylori) antibody and pepsinogens are determined. H. pylori infection is defined as 'H. pylori antibody is positive', 'serum pepsinogen test is positive' and 'medical history of H. pylori eradication'. The prevalence of H. pylori infection is calculated according to birth-year of the subjects. Additionally, associations of H. pylori infection and related-disease with lifestyle, environments, or genetic polymorphism are estimated.

Management information
Registered date
2020 Year 09 Month 05 Day
Last modified on
2020 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047363

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.