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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035678
Receipt No. R000040624
Scientific Title Utility of Diagnostic Molecular Markers for Gastric Cancer Using Gastric Wash
Date of disclosure of the study information 2019/02/01
Last modified on 2019/01/26

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Basic information
Public title Utility of Diagnostic Molecular Markers for Gastric Cancer Using Gastric Wash
Acronym Molecular Markers for Gastric Cancer
Scientific Title Utility of Diagnostic Molecular Markers for Gastric Cancer Using Gastric Wash
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Yasuda
Organization St. Marianna University School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 2-16-1 Sugao Miyamaeku, Kawasaki
TEL +81449778111
Email hyasuda@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Watanabe
Organization Kawasaki Rinko General Hospital
Division name Division of Internal Medicine
Zip code
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)

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 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

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
2019 Year 02 Month 01 Day
Date of IRB
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

Other
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

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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