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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027023
Receipt No. R000030975
Scientific Title A multicenter prospective study of the endoscopic findings of gastric mucosa in background of gastric cancer
Date of disclosure of the study information 2017/04/20
Last modified on 2019/04/19

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Basic information
Public title A multicenter prospective study of the endoscopic findings of gastric mucosa in background of gastric cancer
Acronym Gastric Mucosa in Background of Gastic Cancer
Scientific Title A multicenter prospective study of the endoscopic findings of gastric mucosa in background of gastric cancer
Scientific Title:Acronym Gastric Mucosa in Background of Gastic Cancer
Region
Japan

Condition
Condition gastric cancer/gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify higher risk of endoscopic findings in background mucosa of gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the differentiation of each endoscopic findings in background mucosa according to Kyoto classification between patients with gastric cancer and non-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

Not applicable
Gender Male and Female
Key inclusion criteria Perfomance status 0-2.
Patients who will undergo endoscopic examination at relative institutions.
Patients who agree with investigation for H .pylori infection and gastritis.
Key exclusion criteria Cases with hematemesis or hematochezia
Cases who are less than 20 years old
Cases with surgical gastrectomy
Cases with endoscopic mucosal resection for gastric cancer
Cases that investigator has determined to be inappropriate.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Kawamura
Organization Sendai City Hospital, Miyagi, Japan
Division name Department of Gastroenterology
Zip code 9828502
Address 1-1-1, Asutonagamachi, Taihaku-ku, Sendai, Miyagi 982-8502, Japan.
TEL +81223087111
Email dq8m-kwmr@asahi-net.or.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Kawamura
Organization Sendai City Hospital, Miyagi, Japan
Division name Department of Gastroenterology
Zip code 9828502
Address 1-1-1, Asutonagamachi, Taihaku-ku, Sendai, Miyagi 982-8502, Japan.
TEL +81223087111
Homepage URL
Email dq8m-kwmr@asahi-net.or.jp

Sponsor
Institute Sendai City Hospital, Miyagi, Japan
Institute
Department

Funding Source
Organization Sendai City Hospital, Miyagi, Japan
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 Sendai City Hospital, Miyagi, Japan
Address 1-1-1, Asutonagamachi, taihaku-ku, Sendai, Miyagi, Japan
Tel +81223087111
Email dq8m-kwmr@asahi-net.or.jp

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 04 Month 20 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 Completed
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
2017 Year 04 Month 18 Day
Anticipated trial start date
2017 Year 04 Month 20 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Endoscopic findings: atrophy, grayish white change, diffuse redress, nodular change, RAC, Map-like redress, WOS, LBC

Management information
Registered date
2017 Year 04 Month 17 Day
Last modified on
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030975

Research Plan
Registered date File name
2017/10/18 (3_12)医学研究計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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