UMIN-CTR Clinical Trial

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
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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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