UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032689
Receipt number R000037279
Scientific Title Evaluation of white opaque substance in gastric epithelial tumor detected after H. pylori eradication by administration of vonoprazan
Date of disclosure of the study information 2018/06/01
Last modified on 2018/05/23 17:58:57

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Basic information

Public title

Evaluation of white opaque substance in gastric epithelial tumor detected after H. pylori eradication by administration of vonoprazan

Acronym

Evaluation of WOS in gastric epithelial tumor detected after H. pylori eradication by administration of bonoprazain

Scientific Title

Evaluation of white opaque substance in gastric epithelial tumor detected after H. pylori eradication by administration of vonoprazan

Scientific Title:Acronym

Evaluation of WOS in gastric epithelial tumor detected after H. pylori eradication by administration of bonoprazain

Region

Japan


Condition

Condition

gastric epithelial tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The present study aimed to investigate whether antacid agents increase the density of the WOS in gastric epithelial tumors, especially detected after H. pylori eradication.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in tumor WOS expression (positive proportion) before and after Vonoprazan administration.

Key secondary outcomes

Relationship between WOS expression and fasting gastric juice pH.
Relationship between WOS expression and tumor histopathology (adenoma VS differentiation dominant VS undifferentiated dominant)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Vonoprazan 20 mg administration for 21 days

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

Planned to undergo endoscopic resection (ESD or EMR) for early gastric cancer and gastric adenomas discovered after successful eradication.
2. For early gastric cancer, absolute adaptive lesion and adaptive enlarged lesion are treated as the target lesion according to the gastric cancer treatment guideline.
3. ECOG-performance Status is 0 or 1.
4. For participation in the study, informed consent was obtained.

Key exclusion criteria

Patients within 6 months from the day of eradication
2. Patients with antacid drugs before the first observation (within 7 days)
3. Patients with lesions with ulcers and bleeding which are difficult to observe the surface of the lesion
4. Patients with severe underlying disease
5. Patients with a history of gastrectomy
6. Patients who have complicated mental illness or psychiatric symptoms and seem to be difficult to participate in the study.
7. Other patients who are deemed inappropriate for the trial responsible physician or the test sharing doctor to conduct this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Ueo

Organization

Oita Red Cross Hospital

Division name

Gastroenterology

Zip code


Address

Chiyo-machi, Oita 870-0033

TEL

0975326181

Email

ueo14@athena.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuya Ueo

Organization

Oita Red Cross Hospital

Division name

Gastroenterology

Zip code


Address

Chiyo-machi, Oita 870-0033

TEL

0975326181

Homepage URL


Email

ueo14@athena.ocn.ne.jp


Sponsor or person

Institute

Oita Red Cross Hospital

Institute

Department

Personal name



Funding Source

Organization

Oita Red Cross Hospital

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


Address


Tel


Email



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

2018 Year 06 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


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

Preinitiation

Date of protocol fixation

2018 Year 05 Month 18 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 23 Day

Last modified on

2018 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037279


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name