UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038466 |
|---|---|
| Receipt number | R000042563 |
| Scientific Title | The relationship between serum pepsinogen levels and gastric atrophy |
| Date of disclosure of the study information | 2019/11/02 |
| Last modified on | 2020/10/14 16:04:55 |
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Basic information
Public title
The relationship between serum pepsinogen levels of and gastric atrophy
Acronym
The relationship between serum pepsinogen levels and gastric atrophy
Scientific Title
The relationship between serum pepsinogen levels and gastric atrophy
Scientific Title:Acronym
The relationship between serum pepsinogen levels and gastric atrophy
Region
| Japan |
Condition
Condition
gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between serum pepsinogen levels and gastritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between serum pepsinogen levels and gastritis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Esophagoduodenoscopy. Serum pepsinogen.
Key exclusion criteria
no
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Furuta |
Organization
Hamamatsu University School of Medicine
Division name
Center for clinical research
Zip code
4300906
Address
Handayama 1-20-1, Higashi ku, Hamamatsu shi, Shizuoka ken
TEL
0534352111
takahr99@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu Univesity School of Medicine
Division name
First department of Medicine
Zip code
4300906
Address
Handayama 1-20-1, Higashi ku, Hamamatsu shi, Shizuoka ken
TEL
0534352111
Homepage URL
takahr99@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Hamamatsu , Shizuoka
Tel
0534352111
takahr99@hama-med.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
| 2019 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
h
Publication of results
Unpublished
Result
URL related to results and publications
h
Number of participants that the trial has enrolled
1207
Results
PG I: A0 44.1, A1 40.6 and A2 28.4.
Results date posted
| 2020 | Year | 10 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who were eradicated of H. pylori.
Participant flow
opt out
Adverse events
no
Outcome measures
The levels of PG I and PG II.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 02 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 02 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 01 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2019 | Year | 11 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042563
