UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research about the onset mechanism of the gastric cancer after the antimicrobial treatment for Helicobacter pylori.
Title of the study (Brief title)	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	Kyosuke Goda
Organization	Kawasaki Medical School
Division name	Division of Gastroenterology Department of Internal Medicine
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	Kyosuke Goda
Organization	Kawasaki Medical School
Division name	Division of Gastroenterology Department of Internal Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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