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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024282
Receipt No. R000027976
Scientific Title Investigation of Micro-mucosal Pattern of Gastric Antrum using Magnifying Narrow Band Imaging in Patients with Chronic Atrophic Fundic Gastritis
Date of disclosure of the study information 2016/10/04
Last modified on 2016/10/04

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Basic information
Public title Investigation of Micro-mucosal Pattern of Gastric Antrum using Magnifying Narrow Band Imaging in Patients with Chronic Atrophic Fundic Gastritis
Acronym Investigation of Micro-mucosal Pattern of Gastric Antrum using NBI
Scientific Title Investigation of Micro-mucosal Pattern of Gastric Antrum using Magnifying Narrow Band Imaging in Patients with Chronic Atrophic Fundic Gastritis
Scientific Title:Acronym Investigation of Micro-mucosal Pattern of Gastric Antrum using NBI
Region
Japan

Condition
Condition Atrophic gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the distribution and histology of micro-mucosal pattern in the antrum based on magnifying endoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association among the extent of CAFG, the micro-mucosal pattern, and histology

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Early stage noncardiac gastric cancer who presented to our institution to receive endoscopic submucosal dissection.
Key exclusion criteria History of H.pylori eradication
Gastric resection
Severe organ failure
Anticoagulant or nonsteroidal anti-inflammatory medication within 7 days of this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uedo Noriya
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3, Higashinari-ku, Osaka 537-8511, Japan.
TEL 06-6972-1181
Email uedou-no@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamasaki Yasushi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3, Higashinari-ku, Osaka 537-8511, Japan.
TEL 06-6972-1181
Homepage URL
Email yamazaki-ya@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Other
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
2016 Year 10 Month 04 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
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2016 Year 10 Month 04 Day
Date of closure to data entry
2016 Year 10 Month 04 Day
Date trial data considered complete
2016 Year 10 Month 04 Day
Date analysis concluded
2016 Year 10 Month 04 Day

Other
Other related information N/A

Management information
Registered date
2016 Year 10 Month 04 Day
Last modified on
2016 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027976

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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