UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027524
Receipt number R000031491
Scientific Title Research about the onset mechanism of the gastric cancer after the antimicrobial treatment for Helicobacter pylori.
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/29 11:24:08

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Basic information

Public title

Research about the onset mechanism of the gastric cancer after the antimicrobial treatment for Helicobacter pylori.

Acronym

Research about the onset mechanism of the gastric cancer after the antimicrobial treatment.

Scientific Title

Research about the onset mechanism of the gastric cancer after the antimicrobial treatment for Helicobacter pylori.

Scientific Title:Acronym

Research about the onset mechanism of the gastric cancer after the antimicrobial treatment.

Region

Japan


Condition

Condition

Gstric cancer and chronic gastritis after the Helicobacter pylori antimicrobial treatment

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

It is intended to search the gene expression causing the map-like redness and a background gastric mucosa associated with the second cancer outbreak after the Helicobacter pylori antimicrobial treatment.

Basic objectives2

Others

Basic objectives -Others

We try to perform a genome-wide search using miRNA derived from exosome and to identify new biomarkers associated with the second cancer outbreak after the Helicobacter pylori antimicrobial treatment by analyzing gene expression by microarray.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The gene expression causing the map-like redness and a background gastric mucosa associated with the second cancer outbreak after the Helicobacter pylori antimicrobial treatment.

Key secondary outcomes

New biomarkers associated with the second cancer outbreak after the Helicobacter pylori antimicrobial treatment.


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

40 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients whom gastric cancer developed in after antimicrobial treatment for Helicobacter pylori and control group after antimicrobial treatment that matched the number of years,sex,age.

Key exclusion criteria

Exclusion criteria are history of gastrectomy, and patients with gastric cancer or other malignant lesions, pylori-positive,hemorrhagic diseases, cirrhosis or renal failure.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kyosuke Goda

Organization

Kawasaki Medical School

Division name

Division of Gastroenterology Department of Internal Medicine

Zip code


Address

577 Matsushima Kurashiki City Okayama Prefecture 701-0192 Japan

TEL

086-462-1111

Email

gooooo_ddy@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kyosuke Goda

Organization

Kawasaki Medical School

Division name

Division of Gastroenterology Department of Internal Medicine

Zip code


Address

577 Matsushima Kurashiki City Okayama Prefecture 701-0192 Japan

TEL

086-462-1111

Homepage URL


Email

gooooo_ddy@yahoo.co.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Self funding

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

2017 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

2017 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2017 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

The study will be approved by the Ethical Committee of Kawasaki Medical School.


Management information

Registered date

2017 Year 05 Month 29 Day

Last modified on

2017 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031491


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name