UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study for evaluation of endoscopic screening for gastric cancer
Acronym	Evaluation study of endoscopic screening for gastric cancer
Scientific Title	Comparative study for evaluation of endoscopic screening for gastric cancer
Scientific Title:Acronym	Evaluation study of endoscopic screening for gastric cancer
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of mortality reduction from gastric cancer by endoscopic screening
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Mortality of gastric cancer
Key secondary outcomes	1) All causes mortality/Mortality of all cancers 2) Incidence of gastric cancer 3) Sensitivity/Specificity 4) Rates of adverse effects 5) Cost-effectiveness ratio

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Upper gastrointestinal endoscopy Helicobacter pylori antibody Pepsinogen
Interventions/Control_2	No intervention
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	61 years-old <=
Age-upper limit	61 years-old >=
Gender	Male and Female
Key inclusion criteria	1) 61 years at first screening year for intervention 2) Inhabitants who have lived in Niigata city for more than 3 years before the first screening for intervention
Key exclusion criteria	1) Any cancer patients 2) Individuals who have participated in gastric cancer screening in Niigata city within 2 years 3) Patient who have been in therapy for any gastric diseases 4) Patients who have any serious disease and have excluded from target of endoscopic screening for gastric cancer
Target sample size	6000

Research contact person
Name of lead principal investigator	1st name Chisato Middle name Last name Hamashima
Organization	Teikyo University
Division name	Faculty of Medical Technology
Zip code	173-8606
Address	2-11-1 Kaga Itabashi-ku, Tokyo
TEL	03-3964-1211
Email	chamashi@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Chisato Middle name Last name Hamashima
Organization	Niigata City Medical Association
Division name	Office of Research for Endoscopic Screening
Zip code	9500914
Address	3-3-11, Shichikuyama, Chuo-ku, Niigata-shi, Niigata
TEL	025-247-8900
Homepage URL	http://www.esgcr.jp/
Email	kenshin@esgcr.jp

Sponsor
Institute	Japan Agency for Medical Reaserch and DEvelopment
Institute
Department

Funding Source
Organization	Japan Agency for Medical Reaserch and DEvelopment
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Niigata City Health Community Center Niigata City Medical Association
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Teikyo University
Address	2-11-1 Kaga Itabashi-ku, Tokyo
Tel	0339641211
Email	turb-office@teikyo-u.ac.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	新潟市医師会による内視鏡検診実施認定施設（新潟市）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 03 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	No longer recruiting
Date of protocol fixation	2012 Year 05 Month 29 Day
Date of IRB	2012 Year 05 Month 16 Day
Anticipated trial start date	2012 Year 05 Month 29 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 03 Day
Last modified on	2019 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015904