UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000033785
Receipt No. R000038541
Scientific Title Multicenter retrospective study of clinical, endoscopic and pathological characteristics of autoimmune gastritis
Date of disclosure of the study information 2018/08/18
Last modified on 2020/02/19 (Ver. 7)

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Basic information
Public title Multicenter retrospective study of clinical, endoscopic and pathological characteristics of autoimmune gastritis
Acronym Multicenter retrospective study of AIG
Scientific Title Multicenter retrospective study of clinical, endoscopic and pathological characteristics of autoimmune gastritis
Scientific Title:Acronym Multicenter retrospective study of AIG
Region
Japan

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

Objectives
Narrative objectives1 To obtain comprehensive understanding and to help detect early stage of autoimmune gastritis (AIG) in Japan and formulate managing policy of this disease through examining the clinical, endoscopic and pathological findings
Basic objectives2 Others
Basic objectives -Others To assess frequency and conditions of 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
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Endoscopic findings: Kyoto gastritis classification and other findings like remnant oxyntic mucosa, status of antrum, mucous condition. Findings through indigo carmine dying method or NBI magnifying method. 2) Histological findings of each biopsy site, number of biopsies. 3) Blood sample results: titer of anti-parietal cell antibody, existence of anti-intrinsic factor antibody, PG1, PG 2, PG 1/2, RBC, Hb, Ht, MCV, WBC, platelet, VB12, folic acid, Fe, TSH, anti-thyroglobulin antibody, anti-glutamic acid decarboxylase antibody, blood sugar, HbA1C and others presumed to be related AIG. 4) Helicobacter pylori infection associated data :13C-UBT, anti H. pylori IgG antibody and H. pylori stool antigen. 5) Other associated clinical information, if available.
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
15 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria The patients who were diagnosed as having AIG according to the following tentative criteria.
1)Corpus dominant atrophy on endoscopy
2) Positivity for anti-parietal cell antibody or anti-intrinsic factor antibody
3) Serum gastrin level > 350 pg/ml
Key exclusion criteria The patients who were prescribed proton pomp inhibitor or vonoprazan fumarate and the patients who underwent gastrectomy or had renal failure.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Shuichi
Middle name
Last name Terao
Organization Kakogawa Central City Hospital
Division name Department of gastroenterology
Zip code 6750037
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
1st name Noriko
Middle name
Last name Kakinoki
Organization Kakogawa Central City Hospital
Division name Clinical study and trial center
Zip code 6750037
Address 439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo, 675-0037, Japan
TEL 079-451-5500
Homepage URL
Email n-kakinoki@kakohp.jp

Sponsor
Institute Kakogawa Central City Hospital, Department of Gastroenterology
Institute
Department

Funding Source
Organization Autoimmune gastritis consensus group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Autoimmune gastritis consensus group
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kakogawa Central City Hospital, Clinical study and trial center
Address 439, Honmachi, Kakogawa-cho, Kakogawa, Hyogo, Japan
Tel 079-451-5500
Email n-kakinoki@kakohp.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 08 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/abs/10.1111/den.13500
Number of participants that the trial has enrolled 245
Results 
Repeated incorrect treatments for H. pylori infection due to a false-positive result in 13C-urea breath test, ranked third among the basis for diagnosis of AIG. Associated gastric lesions were type 1 neuroendocrine tumor (11.4%), adenocarcinoma (9.8%). Corpus pan-atrophy was the most common appearance. Remnant oxyntic mucosa was found in 31.5% of the patients. Sticky adherent dense mucus and scattered minute whitish protrusions were observed in approximately 30% of the patients.
Results date posted
2020 Year 02 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 08 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2018 Year 08 Month 14 Day
Date of IRB
2018 Year 08 Month 15 Day
Anticipated trial start date
2018 Year 08 Month 18 Day
Last follow-up date
2019 Year 06 Month 17 Day
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
2019 Year 07 Month 01 Day
Date analysis concluded
2019 Year 07 Month 20 Day

Other
Other related information 1) Registration of the cases who met the criteria from institutions belong to the autoimmune gastritis consensus group.
2) Analysis of clinical, endoscopic and histological characteristics of AIG.
3) Examination of the prevalence and clinical characteristics of accompanied diseases: various autoimmune diseases, anemia, neuroendocrine cell tumor, gastric cancer and other related diseases.
: according to the primary and secondary outcomes.

Management information
Registered date
2018 Year 08 Month 16 Day
Last modified on
2020 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038541