UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of performance characteristics and efficiency of the combination test of serum pepsinogen levels and Helicobacter pylori antibody in stomach cancer screening
Acronym	Evaluation of performance characteristics and efficiency of the combination test of serum pepsinogen levels and Helicobacter pylori antibody in stomach cancer screening
Scientific Title	Evaluation of performance characteristics and efficiency of the combination test of serum pepsinogen levels and Helicobacter pylori antibody in stomach cancer screening
Scientific Title:Acronym	Evaluation of performance characteristics and efficiency of the combination test of serum pepsinogen levels and Helicobacter pylori antibody in stomach cancer screening
Region	Japan

Condition
Condition	Stomach Cancer
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to measure sensitivity and specificity of a screening program for stomach cancer by barium meal X-ray examination according to the risk level classified by the blood test. Another purpose is to capture possible harms from the new screening method, such as false positive, false negative and adverse effects of H. pylori eradication therapy.
Basic objectives2	Others
Basic objectives -Others	Evaluation of efficiency of stomach cancer screening by blood test, and collection of harm of the screening method
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sensitivity and specificity of a barium meal X-ray examination for stomach cancer screening according to the risk level (Group A to D) classified by the blood test
Key secondary outcomes	Possible harms related to the new screening method, such as false positive, false negative and adverse effect due to H. pylori eradication therapy

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Screening of stomach cancer by X-ray
Interventions/Control_2	Screening of stomach cancer by X-ray, serum pepsinogen and anti-Helicobacter pylori immunoglobulin G antibodies
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	40 years-old <=
Age-upper limit	55 years-old >
Gender	Male and Female
Key inclusion criteria	Persons who get screening for stomach cancer between the age of 40 to 54
Key exclusion criteria	Persons with a previous history of stomach cancer Persons with a previous history of undergoing surgery on stomach cancer Persons undergoing treatment for upper gastrointestinal tract disease
Target sample size	5800

Research contact person
Name of lead principal investigator	1st name Mieko Middle name Last name HARADA
Organization	Hachioji City, tokyo
Division name	Public Health Office
Zip code	192-0083
Address	13-18 Asahi-cho, Hachioji-city, Tokyo
TEL	042-645-5111
Email	harada_mieko@city.hachioji.tokyo.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name SHINDO
Organization	Hachioji City, tokyo
Division name	Adult Medical Check-up Section
Zip code	192-8501
Address	3-24-1 Motohongo-cho, Hachioji-city, Tokyo
TEL	042-620-7428
Homepage URL	http://www.city.hachioji.tokyo.jp/hoken_iryo/7303/index.html
Email	shindo_takeshi@city.hachioji.tokyo.jp

Sponsor
Institute	Hachioji-city, Tokyo
Institute
Department

Funding Source
Organization	general account budget in Hachioji-city
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Cancer Center, Japan Hachioji Medical Association
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel	03-3542-2511
Email	irst@ml.res.ncc.go.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	八王子市（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 15 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	4232
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	2014 Year 09 Month 10 Day
Date of IRB	2014 Year 08 Month 21 Day
Anticipated trial start date	2014 Year 10 Month 15 Day
Last follow-up date	2028 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 10 Month 14 Day
Last modified on	2020 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017778