UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of Diagnostic Molecular Markers for Gastric Cancer Using Gastric Wash
Title of the study (Brief title)	Molecular Markers for Gastric Cancer
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	to detect the candidate molecular markers of gastric cancer
Basic objectives2	Others
Basic objectives -Others	to detect the candidate molecular markers of gastric cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to detect the candidate molecular markers of gastric cancer
Key secondary outcomes

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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. patient who gastric neoplasia with H. pylori infection 2. patient who gastritis with H. pylori infection
Key exclusion criteria	1. under 20 years old 2. have some issues to entry 3, pregnant 4. inappropriate patients
Target sample size	300

Research contact person
Name of lead principal investigator	Hiroshi Yasuda
Organization	St. Marianna University School of Medicine
Division name	Division of Gastroenterology and Hepatology
Address	2-16-1 Sugao Miyamaeku, Kawasaki
TEL	+81449778111
Email	hyasuda@marianna-u.ac.jp

Public contact
Name of contact person	Yoshiyuki Watanabe
Organization	Kawasaki Rinko General Hospital
Division name	Division of Internal Medicine
Address	3-13-1 Nakajima Kawasakiku Kawasaki
TEL	+81442339336
Homepage URL
Email	ponponta@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kawasaki Rinko General Hospital
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	総合川崎臨港病院（神奈川県） 横浜市立大学附属病院　消化器内科（神奈川県） 聖マリアンナ医科大学　東横病院（神奈川県） 藤田保健衛生大学病院　消化管内科（愛知県） 日本医科大学武蔵小杉病院　消化管内科（神奈川県）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 02 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	N/A

Management information
Registered date	2019 Year 01 Month 26 Day
Last modified on	2019 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040624