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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032192
Receipt No. R000036714
Scientific Title Prevalence of type A gastritis and relation with H. pylori infection in severe atrophic gastritis
Date of disclosure of the study information 2018/07/01
Last modified on 2020/02/21

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Basic information
Public title Prevalence of type A gastritis and relation with H. pylori infection in severe
atrophic gastritis
Acronym Prevalence of type A gastritis in severe
atrophic gastritis
Scientific Title Prevalence of type A gastritis and relation with H. pylori infection in severe
atrophic gastritis
Scientific Title:Acronym Prevalence of type A gastritis in severe
atrophic gastritis
Region
Japan

Condition
Condition severe
atrophic gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the prevalence of autoimmune gastritis in severe atrophic gastritis.
Basic objectives2 Others
Basic objectives -Others To investigate the relation between autoimmune gastritis and H. pylori infection.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of autoimmune gastritis in severe atrophic gastritis
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Blood collection is scheduled for upper gastrointestinal endoscopy and screening for organic diseases among patients who have gastrointestinal symptoms or for gastric cancer screening examinations. Our patients with Severe atrophic gastritis.
Key exclusion criteria gastric surgery, PPI administration, renal failure
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomoari
Middle name
Last name Kamada
Organization Kawasaki Medical School
Division name Dept of Health Care Medicine
Zip code 700-8505
Address 2-6-1, Nakasange, Kita-ku, Okayama
TEL 086-225-2111
Email tkamada@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Tomoari
Middle name
Last name Kamada
Organization Kawasaki Medical School
Division name Dept of Health Care Medicine
Zip code 700-8505
Address 2-6-1, Nakasange, Kita-ku, Okayama
TEL 086-225-2111
Homepage URL
Email tkamada@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kawasaki Medical School
Address 2-6-1, Nakasange, Kita-ku, Okayama
Tel 086-225-2111
Email tkamada@med.kawasaki-m.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
2018 Year 07 Month 01 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 30
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
2018 Year 04 Month 11 Day
Date of IRB
2008 Year 05 Month 17 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 04 Month 11 Day
Last modified on
2020 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036714

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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