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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015434
Receipt No. R000017778
Scientific Title Evaluation of performance characteristics and efficiency of the combination test of serum pepsinogen levels and Helicobacter pylori antibody in stomach cancer screening
Date of disclosure of the study information 2014/10/15
Last modified on 2020/05/11

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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/ctr_e/ctr_view.cgi?recptno=R000017778

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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