UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033610 |
|---|---|
| Receipt number | R000038298 |
| Scientific Title | Prospective and retrospective clinico-pathological study of autoimmune gastritis |
| Date of disclosure of the study information | 2018/08/04 |
| Last modified on | 2024/02/06 08:54:12 |
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Basic information
Public title
Prospective and retrospective clinico-pathological study of autoimmune gastritis
Acronym
PRCP- AIG study
Scientific Title
Prospective and retrospective clinico-pathological study of autoimmune gastritis
Scientific Title:Acronym
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
200
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, Japan
TEL
079-451-5500
Homepage URL
n-kakinoki@kakohp.jp
Sponsor or person
Institute
Kakogawa Central City Hospital
Institute
Department
Personal name
Shuichi Terao
Funding Source
Organization
Kakogawa Central City Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
加古川中央市民病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
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
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038298
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
