UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055147 |
|---|---|
| Receipt number | R000062997 |
| Scientific Title | A Multi-Center Retrospective Observational Study on Endoscopic Atrophic Classification and Clinical Stages of Autoimmune Gastritis |
| Date of disclosure of the study information | 2024/08/05 |
| Last modified on | 2025/08/04 16:21:43 |
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Basic information
Public title
A multi-center retrospective, observational study to establish endoscopic staging of autoimmune gastritis
Acronym
A study of the endoscopic stage of autoimmune gastritis
Scientific Title
A Multi-Center Retrospective Observational Study on Endoscopic Atrophic Classification and Clinical Stages of Autoimmune Gastritis
Scientific Title:Acronym
MACC
Region
| Japan |
Condition
Condition
Autoimmune gastritis(AIG)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the endoscopic atrophic stage classification of autoimmune gastritis(AIG-AS) can be a useful indicator for evaluating the disease course of AIG, including the progression of clinical and laboratory findings of AIG and the frequency of concomitant diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of complicated gastric neoplastic lesions and concomitant diseases, and severity of laboratory findings in each stage (stage 0, 1, 2, 3) of endoscopic remnant oxyntic mucosa (ROM) in autoimmune gastritis
Key secondary outcomes
Validity of ROM staging according to status of possible concomitant Hp infection
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients receiving proton pump inhibitors (PPIs) or potassium ion-competitive acid blockers (PCAb)
: Cases in which PPI or PCAb was administered within the past year (except for cases in which PPI or PCAb was used for a short period of time as Hp eradication therapy at least 3 months prior to the date of endoscopy).
2) Cases in which immunosuppressive agents were administered.
3) Cases in which objective evaluation of endoscopic ROM extent is difficult.
4) Cases in which the patient or his/her representative refuses to participate in the study.
5) Cases in which the principal/participating physicians and the Central Judging Committee determine that the patient is not suitable for this study.
Key exclusion criteria
1) Patients receiving proton pump inhibitors (PPIs) or potassium ion-competitive acid blockers (PCAb)
: Cases in which PPI or PCAb was administered within the past year (except for cases in which PPI or PCAb was used for a short period of time as Hp eradication therapy at least 3 months prior to the date of endoscopy)
2) Cases in which immunosuppressive agents were administered
3) Cases in which objective evaluation of endoscopic ROM extent is difficult
4) Cases in which the patient or his/her representative refuses to participate in the study
5) Cases in which the principal/participating physicians and the Central Judging Committee determine that the patient is not suitable for this study.
Target sample size
500
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 Internal medicine, Department of Gastroenterology
Zip code
6758611
Address
439, Honmachi, Kakogawa cho, Kakogawa city, Hyogo, Japan
TEL
079-451-5500
stshiratodai2@gmail.com
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Kakinoki |
Organization
Kakogawa Central City Hospital
Division name
Clinical Research and Clinical Trial Center
Zip code
6758611
Address
439, Honmachi, Kakogawa cho, Kakogawa city, Hyogo, Japan
TEL
079-451-5500
Homepage URL
n-kakinoki@kakohp.jp
Sponsor or person
Institute
Study Group for the Establishment of Diagnostic Criteria for Autoimmune Gastritis and Its Clinicopathological Significance
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Kakogawa Central City Hospital, Clinical Research and Clinical Trial Center
Address
439, Honmachi, Kakogawa cho, Kakogawa city, 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
加古川中央市民病院 (兵庫県) Kakogawa Central City Hospital (Hyogo)
石川記念会HITO病院 (愛媛県) Ishikawa Kinen Kai HITO Medical Center (Ehime)
井野辺病院 (大分県) Inobe Hospital (Ooita）
宇治徳洲会病院 (京都府) Uji Tokushukai Medical Center (Kyoto)
川崎医科大学総合医療センター（岡山県）Kawasaki-Medical School General Medical Center (Okayama)
がん研有明病院（東京都） The Cancer Institute Hospital of JFCR（Tokyo）
杏林大学医学部付属病院 (東京都) Kyorin University Hospital (Tokyo）
春藤内科胃腸科 (徳島県) Syunto Clinic (Tokushima)
淳風会健康管理センター (岡山県) Junpukai Health maintenance Center (Okayama)
聖隷浜松病院 (静岡県) Seirei Hamamatsu General Hospital (Shizuoka)
湘南鎌倉総合病院 (神奈川県) Shonan Kamakura General Hospital (Kanagawa)
地域医療機能推進機構滋賀病院 (滋賀県) Japan Community Health Care Organization Shiga Hospital (Shiga)
東京歯科大学市川総合病院 (東京都) Tokyo Dental College Ichikawa General Hospital (Tokyo)
東京女子医科大学医学部付属病院 (東京都) Tokyo Women’s Medical University Hospital (Tokyo)
徳島県総合健診センター（徳島県） Tokushima Sougou Kenshin Center (Tokushima)
徳島大学医学部付属病院 (徳島県） Tokushima University Hospital (Tokushima)
藤枝市立総合病院 (静岡県) Fujieda Municipal General Hospital (Shizuoka)
ふるた内科クリニック (静岡県) Furuta Naika Clinic (Shizuoka)
北海道大学医学部付属病院 (北海道) Hokkaido University Hospital (Hokkaido)
北海道対がん協会 札幌がん検診センター (北海道) Hokkaido Cancer Society Sapporo Cancer Screening Center (Hokkaido)
松山赤十字病院 (愛媛県) Matsuyama Red Cross Hospital (Ehime)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 05 | 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
303
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 04 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 28 | Day |
Other
Other related information
Required assessment data
Extent of remnant oxyntic mucosa (ROM) (stage 0, 1, 2, 3)
Serum markers: PCA (fold), Gastrin level, Hb, MCV,
(For cases with a history of Fe and vitamin B12 administration, do not use Hb and MCV data, but enter the respective "treatment history".)
IFA (required if PCA is unmeasured or negative)
Concomitant neoplastic disease: gastric cancer, NET, hyperplastic polyps and the date of their diagnosis
Hp infection status (overall judgment)
: 3 choices 1) previous Hp infection or uninfected, 2) clear previous Hp infection, 3) current Hp infection
AIG pathologic staging: biopsies taken from at least two sites: the greater curvature of antrum and upper body
Management information
Registered date
| 2024 | Year | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062997
