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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040053
Receipt No. R000045665
Scientific Title A comparative observational study of patients with atrophic gastritis to examine the standard values of serum gastrin and pepsinogen I, II, I/II ratio related to diagnostic criteria for autoimmune gastritis
Date of disclosure of the study information 2020/04/04
Last modified on 2020/10/04

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Basic information
Public title A comparative observational study of patients with atrophic gastritis to examine the standard values of serum gastrin and pepsinogen related to diagnostic criteria for autoimmune gastritis
Acronym Comparative observation study on diagnostic criteria for autoimmune gastritis
Scientific Title A comparative observational study of patients with atrophic gastritis to examine the standard values of serum gastrin and pepsinogen I, II, I/II ratio related to diagnostic criteria for autoimmune gastritis
Scientific Title:Acronym Comparative observation study on diagnostic criteria for autoimmune gastritis
Region
Japan

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

Objectives
Narrative objectives1 Set gastrin and PG values for picking up autoimmune gastritis (AIG) and optimal gastrin and PG cutoff values to distinguish between AIG and non-AIG
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gastrin values, PG I, II, I / II values for AIG and non-AIG cases
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
90 years-old >
Gender Male and Female
Key inclusion criteria EGD between April 1 2011 and April 30 2020, with atrophic gastritis, for which gastrin or PG was measured as clinical necessity or as a screening item. The registration period will be November 30, 2020 from the approval date of each facility ethics committee.
They are classified and registered in the following a)-f).
a) AIG group (pathologically matched + autoantibody positive) group: Pathological diagnostic criteria in the attached draft 3) Satisfies # 1 or # 1 + # 2 and is positive for PCA or IFA
b) AIG group (pathology unknown + autoantibody positive) group: no histological examination or pathological criteria not evaluated, and PCA or IFA is positive.
c) Non-AIG (pathological non-AIG + autoantibody negative) group: Hp gastritis (Hp eradication) that does not satisfy the attached draft pathological diagnostic criteria # 1 or # 2 and is PCA (-) and IFA (-) (including Hp eradicate successful examples)
d) Non-AIG (pathological unknown + autoantibody negative) group: Hp gastritis (including successful cases of Hp eradication) for which no histological examination or pathological criteria have been evaluated, and which is PCA (-) and IFA (-).
e) Non-AIG (pathological non-AIG + PCA (-) group: Hp gastritis that does not meet the attached draft pathological diagnostic criteria # 1 or # 2 and is PCA negative (including successful Hp eradication).
f) Non-AIG (pathologic non-AIG + PCA (-) group: Endoscopic atrophic gastritis (Hp infection history Is not clear).
Key exclusion criteria After gastrectomy, taking proton pump inhibitor (PPI) or vonoprazan fumarate, renal failure
Target sample size 360

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 none
Organization
Division
Category of Funding Organization Self funding
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
2020 Year 04 Month 04 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 Open public recruiting
Date of protocol fixation
2020 Year 05 Month 01 Day
Date of IRB
2020 Year 08 Month 01 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 05 Month 31 Day

Other
Other related information None

Management information
Registered date
2020 Year 04 Month 04 Day
Last modified on
2020 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045665

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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