UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015434 |
|---|---|
| Receipt number | 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 11:55:29 |
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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
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
shindo_takeshi@city.hachioji.tokyo.jp
Sponsor or person
Institute
Hachioji-city, Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017778
