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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030407
Receipt No. R000034724
Scientific Title Effect of acid suppressor in serum level of gastrin in Japanese patients with gastric ulcer after ESD
Date of disclosure of the study information 2019/01/01
Last modified on 2019/06/28

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Basic information
Public title Effect of acid suppressor in serum level of gastrin in Japanese patients with gastric ulcer after ESD
Acronym Effect of acid suppressor in serum level of gastrin
Scientific Title Effect of acid suppressor in serum level of gastrin in Japanese patients with gastric ulcer after ESD
Scientific Title:Acronym Effect of acid suppressor in serum level of gastrin
Region
Japan

Condition
Condition gastric cancer post ESD
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the difference in serum gastrin level after using acid suppressors
Basic objectives2 Others
Basic objectives -Others To clarify the clinical features of patients who revealed the increased gastrin level after using PPI/P-Cab.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the difference in serum gastrin level after using acid suppressors
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient who received endoscopic submucosal dissection of early gastric cancer.
2) Patients whose sera were collected before and after using acid suppressors.
3) Patients with written informed consent.
4) Over 20 years.
Key exclusion criteria 1) Patients with allergic reaction for PPI/P-Cab.
2) Under 20 years old.
3) Patients with previous gasterectomy.
4) Patients with insufficient treatment by ESD.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Ito
Organization Hiroshima University Hospital
Division name Gastroenterology an Metabolism
Zip code 7348551
Address 1-2-3 Kasumi Minami-ku Hiroshima
TEL +81-82-257-5191
Email maito@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Ito
Organization Hiroshima University Hospital
Division name Gastroenterology an Metabolism
Zip code 7348551
Address 1-2-3 Kasumi Minami-ku Hiroshima
TEL +81-82-257-5191
Homepage URL
Email maito@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima university
Institute
Department

Funding Source
Organization AstraZeneca
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for integrated medical research Hiroshima University Hospital
Address 1-2-3 Kasumi Minanmi-ku Hirosima
Tel 082-257-1752
Email protocol@cimr.hiroshima-u.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 01 Month 01 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 150
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
2018 Year 01 Month 01 Day
Date of IRB
2018 Year 12 Month 18 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 12 Month 15 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034724

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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