UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015790
Receipt number R000018373
Scientific Title Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in the treatment of ulcers PPI after endoscopic treatment(ESD:endoscopic submucosal dissection) of gastric neoplasm
Date of disclosure of the study information 2014/11/29
Last modified on 2016/01/07 17:01:08

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Basic information

Public title

Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in the treatment of ulcers PPI after endoscopic treatment(ESD:endoscopic submucosal dissection) of gastric neoplasm

Acronym

Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in PPI treatment of after ESD

Scientific Title

Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in the treatment of ulcers PPI after endoscopic treatment(ESD:endoscopic submucosal dissection) of gastric neoplasm

Scientific Title:Acronym

Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in PPI treatment of after ESD

Region

Japan


Condition

Condition

early gastric cancer, gastric adenoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

When should Helicobacter pylori be eradicated in patients who underwent endoscopic submucosal dissection for gastric neoplasm to prevent complications?

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the healing rates of artificial ulcer at 4 and 8 weeks late of ESD treatment

Key secondary outcomes

ESD-related complications such as bleeding or perforation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

eradication of H. pylori before ESD treatment

Interventions/Control_2

eradication of H. pylori after ESD treatment

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

Patients who were diagnosed as early gastric cancer or gastric adenoma and are considered as the indication of ESD treatment

Key exclusion criteria

1.H.pylor-negative patients
2.Patiants with surgical history of stomach
3.patients who are pregnant or nursing
4.patients who are diagnosed as unsuitable for this trial by investigatior

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yashiro Yoshizawa

Organization

Seirei Hamamatsu General Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-12-12 Sumiyoshi Naka-ku Hamamatsu Shizuoka Japan

TEL

053-474-2222

Email

yashiro1224@sis.seirei.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yashiro Yoshizawa

Organization

Seirei Hamamatsu General Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-12-12 Sumiyoshi Naka-ku Hamamatsu Shizuoka Japan

TEL

053-474-2222

Homepage URL


Email

yashiro1224@sis.seirei.or.jp


Sponsor or person

Institute

Department of Gastroenterology,Seirei Hamamatsu General Hospital

Institute

Department

Personal name



Funding Source

Organization

Seirei Hamamatsu General Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hamamatsu University school of Medicine

Name of secondary funder(s)

Hamamatsu University school of Medicine


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

2014 Year 11 Month 29 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

Completed

Date of protocol fixation

2013 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 05 Month 10 Day

Date trial data considered complete


Date analysis concluded

2015 Year 05 Month 10 Day


Other

Other related information



Management information

Registered date

2014 Year 11 Month 29 Day

Last modified on

2016 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018373


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name