UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033785 |
|---|---|
| Receipt number | 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 17:19:13 |
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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
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
n-kakinoki@kakohp.jp
Sponsor or person
Institute
Kakogawa Central City Hospital, Department of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038541
