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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033610
Receipt No. R000038298
Official scientific title of the study Prospective and retrospective clinico-pathological study of autoimmune gastritis
Date of disclosure of the study information 2018/08/04
Last modified on 2018/08/02

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Basic information
Official scientific title of the study Prospective and retrospective clinico-pathological study of autoimmune gastritis
Title of the study (Brief title) PRCP- AIG study
Region
Japan

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

Objectives
Narrative objectives1 To examine clinico-pathological findings of autoimmune gastritis (AIG), especially early phase of those and contribute to detect AIG and establish appropriate management of this disease.
Basic objectives2 Others
Basic objectives -Others To detect associated diseases of autoimmune polyendocrine syndrome(APS), anemia (macrocytic anemia and iron deficiency anemia), gastric neuroendocrine cell tumor and gastric cancer and to assess the risk factors of those associated diseases
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Endoscopic findings, Pathological findings, titer of anti-parietal cell antibody, existence of anti-intrinsic factor antibody and existence of Helicobacter pylori infection at the first diagnose establishment year and 1 year, 2 years, 3 years, 4 years and 5 years after the first year
Key secondary outcomes Existence of accompanied diseases: neuroendocrine cell tumor, gastric cancer, anemia, autoimmune diseases (thyroid diseases, Type1 diabetes, Sjogren's syndrome and other autoimmune diseases), pepsinogen (PG) 1, PG 2 and PG 1/2 at the first diagnose establishment year and 1 year, 2 years, 3 years, 4 years and 5 years after the first year

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
15 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria The patients who submitted the consent form of this study after establishment of diagnosis as having corpus dominant atrophy on endoscopy
Key exclusion criteria The patients who are prescribed proton pomp inhibitor or vonoprazan fumarate or who are enabled to discontinue the drugs earlier than 1 month before endoscopic examination.
Target sample size 100

Research contact person
Name of lead principal investigator Shuichi Terao
Organization Kakogawa Central City Hospital
Division name Department of gastroenterology
Address 439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo, 675-0037, Japan
TEL 079-451-5500
Email s-terao@kakohp.jp

Public contact
Name of contact person Shuichi Terao
Organization Kakogawa Central City Hospital
Division name Department of gastroenterology
Address 439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo, 675-0037, Japan
TEL 079-451-5500
Homepage URL
Email s-terao@kakohp.jp

Sponsor
Institute Kakogawa Central City Hospital
Institute
Department

Funding Source
Organization Kakogawa Central City Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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 08 Month 04 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 17 Day
Anticipated trial start date
2018 Year 08 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information 1) Confirmation of autoimmune gastritis (AIG) by endoscopic, histological and serological findings.
2) Examination of characteristics of endoscopic appearance of AIG.
3) Examination of characteristics of histological findings of AIG.
: according to the primary and secondary outcomes.

Management information
Registered date
2018 Year 08 Month 02 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038298

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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