UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041698
Receipt number 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 13:50:56

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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 or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



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

Value
https://center6.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