UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030407
Receipt number 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 2020/05/18 13:55:53

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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 or person

Institute

Hiroshima university

Institute

Department

Personal name



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

Completed

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

2020 Year 12 Month 31 Day

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

2020 Year 05 Month 18 Day



Link to view the page

Value
https://center6.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