UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060599 |
|---|---|
| Receipt number | R000069316 |
| Scientific Title | Evaluation of the Acceptability of Endoscopic Gastric Cancer Screening |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/02/06 12:28:32 |
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Basic information
Public title
Evaluation of the Acceptability of Endoscopic Gastric Cancer Screening
Acronym
Evaluation of the Acceptability of Endoscopic Gastric Cancer Screening
Scientific Title
Evaluation of the Acceptability of Endoscopic Gastric Cancer Screening
Scientific Title:Acronym
Evaluation of the Acceptability of Endoscopic Gastric Cancer Screening
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In Japan, endoscopic screening has been implemented as a population-based gastric cancer screening program since 2016, following the revision of the Ministry of Health, Labour and Welfare guidelines. The program targets adults aged 50 years or older, with biennial screening recommended. However, limited availability of medical institutions capable of providing endoscopic screening has prevented some municipalities from offering screening to all eligible residents. Moreover, the prevalence of Helicobacter pylori infection, a major risk factor for gastric cancer, has been declining, particularly among younger generations, potentially reducing the effectiveness and cost-effectiveness of the current screening strategy. Therefore, optimizing both screening strategies and delivery systems may require increasing the starting age or extending the screening interval to reduce the required number of endoscopic examinations. This study aims to assess screening participants' understanding, satisfaction, and acceptance of potential changes to the current gastric cancer endoscopic screening strategy through a questionnaire survey conducted in Japanese municipalities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of individuals agreeing with the proposal to raise the age eligibility and extend the screening interval for endoscopic gastric cancer screening.
Key secondary outcomes
1. Percentage of individuals who know that Helicobacter pylori is a cause of stomach cancer.
2. Percentage of individuals who know that the infection rate of Helicobacter pylori is declining.
3. Percentage of individuals who know that the purpose of stomach cancer screening is not only early detection but also reducing stomach cancer mortality.
4. Percentage of individuals who know the target age group and screening interval for stomach cancer endoscopy.
5. Percentage of individuals agreeing to raise the age for gastric cancer endoscopic screening to 60.
6. Percentage of individuals agreeing to extend the interval for gastric cancer endoscopic screening to 5 or 10 years.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents applying for gastric cancer endoscopic screening in Fuchu City, Tokyo and Ichikawa City, Chiba Prefecture, in fiscal year 2026
Key exclusion criteria
1. Individuals who do not consent to the questionnaire survey
2. Individuals who have undergone total gastrectomy
3. Individuals who undergo regular upper gastrointestinal endoscopy for any reason
4. Individuals with bleeding tendencies or suspected bleeding tendencies
5. Individuals with severe diseases of the pharynx, nasal cavity, etc., preventing endoscope insertion
6. Individuals with respiratory failure
7. Individuals whose general condition is deemed too poor to tolerate endoscopy
8. Individuals currently hospitalized, regardless of the type of disease
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi, Chiba, Japan
TEL
047-375-1111
ishibashi-gast@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14, Konodai, Ichikawa-shi, Chiba, Japan
TEL
047-375-1111
Homepage URL
ishibashi-gast@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Ichikawa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Institutional Reviw Board
Address
4-3, Kozunomori, Narita-shi, Chiba
Tel
0476-20-7708
rinri_md@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2026 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Inclusion and Mailing of the Questionnaire Invitation with Screening Materials>
In Fuchu City, when the Health Promotion Division prepares screening-related materials (e.g., screening forms) for applicants, a questionnaire invitation letter will be enclosed and mailed.
In Ichikawa City, when the Health Support Division prepares the screening voucher and information postcard for applicants, a QR code linking to the questionnaire, along with an invitation message, will be printed on the reverse side of the postcard and mailed.
<Access to the Google Form via QR Code by Applicants (Study Consent and Questionnaire Response)>
Applicants who receive the mailed materials will access a Google Form via the QR code provided in the questionnaire invitation, where they will provide online informed consent and complete the questionnaire. The questionnaire will assess the following items:
1. Age and sex
2. Basic knowledge of gastric cancer: awareness that Helicobacter pylori infection is the primary cause of gastric cancer and that the prevalence of H. pylori infection has markedly declined among individuals aged <60 years
3. Understanding of the purpose of screening
4. Understanding of the screening program: awareness of the current eligibility criteria for gastric cancer endoscopic screening (aged >49 years, biennial interval)
5. Acceptance of changes in screening strategy: willingness to accept raising the starting age to 60 years and/or extending the screening interval to 5 or 10 years
<Compilation of Questionnaire Data at the Data Center>
The data center (Medical Research Support Co., Ltd.) will compile responses collected through the Google Form and compare results by municipality, age group, and sex of the participants.
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069316
