UMIN-CTR Clinical Trial

Basic information
Public title	Research on development of gastric cancer screening system based on individual risk
Acronym	Research on gastric cancer screening based on individual risk
Scientific Title	Research on development of gastric cancer screening system based on individual risk
Scientific Title:Acronym	Research on gastric cancer screening based on individual risk
Region	Japan

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

Objectives
Narrative objectives1	Screening interval extension of gastric cancer screening for low-risk group for gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cumulative incidence of gastric cancer
Key secondary outcomes	Sensitivity, specificity, rate of adverse effects

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Helicobacter pylori antibody (baseline, 1 time)
Interventions/Control_2	Serum pepsinogen (baseline, 1 time)
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	50 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1)50 years to 69 years at baseline screening for gastric cancer 2)Obtaining informed consent for participation in research screening
Key exclusion criteria	1) having serious diseases 2) having any treatments for cancers 3) having any gastric disease 4) participants in the preceding study in Niigata city
Target sample size	47100

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Fukao
Organization	Miyagi Cancer Association
Division name	Research Devision
Zip code	980-0011
Address	5-7-30 Kamizugi Sendai
TEL	022-263-1525
Email	afukao@med.id.yamagata-u.ac.jp

Public contact
Name of contact person	1st name Chisato Middle name Last name Hamashima
Organization	Teikyo University
Division name	Faculty of Medical Techmology
Zip code	1738606
Address	2-11-1 Kaga Itabashi-ku, Tokyo
TEL	0339641211
Homepage URL	http://j-sasg.jp/
Email	chamashi@med.teikyo-u.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Miyagi Cancer Association
Address	5-7-30 Kamisugi Aiba-ku Sendai
Tel	022-263-1525
Email	kkato@st.cat-v.ne.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	宮城県対がん協会（宮城県）、新潟市医師会、鳥取東部医師会（鳥取市）、鳥取西部医師会（米子市）盛岡市医師会、前橋市医師会、金沢市医師会、JA秋田県厚生連由利組合病院（秋田県由利本荘市）

Other administrative information
Date of disclosure of the study information	2017 Year 04 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	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 25 Day
Date of IRB	2016 Year 12 Month 28 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2023 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	2017 Year 01 Month 25 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=R000029627