UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040053 |
|---|---|
| Receipt number | R000045665 |
| Scientific Title | A comparative observational study of patients with atrophic gastritis to examine the standard values of serum gastrin and pepsinogen I, II, I/II ratio related to diagnostic criteria for autoimmune gastritis |
| Date of disclosure of the study information | 2020/04/04 |
| Last modified on | 2023/10/07 09:41:49 |
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Basic information
Public title
A comparative observational study of patients with atrophic gastritis to examine the standard values of serum gastrin and pepsinogen related to diagnostic criteria for autoimmune gastritis
Acronym
Comparative observation study on diagnostic criteria for autoimmune gastritis
Scientific Title
A comparative observational study of patients with atrophic gastritis to examine the standard values of serum gastrin and pepsinogen I, II, I/II ratio related to diagnostic criteria for autoimmune gastritis
Scientific Title:Acronym
Comparative observation study on diagnostic criteria for autoimmune gastritis
Region
| Japan |
Condition
Condition
atrophic gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Set gastrin and PG values for picking up autoimmune gastritis (AIG) and optimal gastrin and PG cutoff values to distinguish between AIG and non-AIG
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastrin values, PG I, II, I / II values for AIG and non-AIG cases
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
EGD between April 1 2011 and April 30 2020, with atrophic gastritis, for which gastrin or PG was measured as clinical necessity or as a screening item. The registration period will be November 30, 2020 from the approval date of each facility ethics committee.
They are classified and registered in the following a)-f).
a) AIG group (pathologically matched + autoantibody positive) group: Pathological diagnostic criteria in the attached draft 3) Satisfies # 1 or # 1 + # 2 and is positive for PCA or IFA
b) AIG group (pathology unknown + autoantibody positive) group: no histological examination or pathological criteria not evaluated, and PCA or IFA is positive.
c) Non-AIG (pathological non-AIG + autoantibody negative) group: Hp gastritis (Hp eradication) that does not satisfy the attached draft pathological diagnostic criteria # 1 or # 2 and is PCA (-) and IFA (-) (including Hp eradicate successful examples)
d) Non-AIG (pathological unknown + autoantibody negative) group: Hp gastritis (including successful cases of Hp eradication) for which no histological examination or pathological criteria have been evaluated, and which is PCA (-) and IFA (-).
e) Non-AIG (pathological non-AIG + PCA (-) group: Hp gastritis that does not meet the attached draft pathological diagnostic criteria # 1 or # 2 and is PCA negative (including successful Hp eradication).
f) Non-AIG (pathologic non-AIG + PCA (-) group: Endoscopic atrophic gastritis (Hp infection history Is not clear).
Key exclusion criteria
After gastrectomy, taking proton pump inhibitor (PPI) or vonoprazan fumarate, renal failure
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | TOMOARI |
| Middle name | |
| Last name | KAMADA |
Organization
Kawasaki Medical School
Division name
Dept. of Health Care Medicine
Zip code
700-8505
Address
2-6-1, Nakasange, Kita-ku, Okayama
TEL
086-225-2111
tkamada@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | TOMOARI |
| Middle name | |
| Last name | KAMADA |
Organization
Kawasaki Medical School
Division name
Dept. of Health Care Medicine
Zip code
700-8505
Address
2-6-1, Nakasange, Kita-ku, Okayama
TEL
086-225-2111
Homepage URL
tkamada@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
none
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
Kawasaki Medical School
Address
2-6-1, Nakasange, Kita-ku, Okayama
Tel
086-225-2111
tkamada@med.kawasaki-m.ac.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
| 2020 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
360
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
Main results already published
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045665
| 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 |
