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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022204
Receipt No. R000024916
Official scientific title of the study Detection of early gastric cancer using image-enhanced endoscopy
Date of disclosure of the study information 2016/05/04
Last modified on 2017/02/21

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Basic information
Official scientific title of the study Detection of early gastric cancer using image-enhanced endoscopy
Title of the study (Brief title) Detection of early gastric cancer using image-enhanced endoscopy
Region
Japan

Condition
Condition atrophic gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate detection of early gastric cancer usig image-enhanced endoscopy for patients with atrophic gastritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes detection rate of early 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 patients who undergo EGD with atrophic gastritis
Key exclusion criteria post gastrectomy
Target sample size 500

Research contact person
Name of lead principal investigator Hiroyuki Imaeda
Organization Saitama Medical University
Division name Department of Gastroenterology
Address Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1667
Email imaedahi@saitama-med.ac.jp

Public contact
Name of contact person Hiroyuki Imaeda
Organization Saitama Medical University
Division name Department of Gastroenterology
Address Morohongo 38, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1667
Homepage URL
Email imaedahi@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
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
2016 Year 05 Month 04 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 03 Month 23 Day
Anticipated trial start date
2016 Year 04 Month 05 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 First, conventional endoscopy
Second, BLI mode and LCI mode
Third, endoscopy using indigocarmine dye spraying
Finally, pathological diagnosis by biopsy specimen

Management information
Registered date
2016 Year 05 Month 04 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024916

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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