UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038466
Receipt No. 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 (Ver. 4)

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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
Email 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
Email takahr99@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042563