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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027524
Receipt No. 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

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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
Institute Kawasaki Medical School
Institute
Department

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
URL(English) https://upload.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


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