UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057733 |
|---|---|
| Receipt number | R000065929 |
| Scientific Title | A study on improving the uptake rate of esophagogastroduodenoscopy based on gastric cancer risk stratification by mailed examination |
| Date of disclosure of the study information | 2025/04/28 |
| Last modified on | 2026/04/28 16:53:29 |
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Basic information
Public title
A study on improving the uptake rate of esophagogastroduodenoscopy based on gastric cancer risk stratification by mailed examination
Acronym
A study on improving the uptake rate of esophagogastroduodenoscopy based on gastric cancer risk stratification by mailed examination
Scientific Title
A study on improving the uptake rate of esophagogastroduodenoscopy based on gastric cancer risk stratification by mailed examination
Scientific Title:Acronym
A study on improving the uptake rate of esophagogastroduodenoscopy based on gastric cancer risk stratification by mailed examination
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Provide gastric cancer risk stratification tests (ABC screening) that can be performed at home to those who have not yet undergone health checkup, and examine whether recommendations for secondary screening based on the results will lead to esophagogastroduodenoscopy examinations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in behavior change stages by transtheoretical model (TTM)
Key secondary outcomes
Statistical analysis of gastric disease and patient background information for those who underwent endoscopy after explanation of ABC screening results
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Gastric cancer risk stratification test [ABC screening]
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who are 18 years of age or older at the time of obtaining consent
(2) Those who have agreed to participate in this study
(3) Those who have not undergone cancer screening or have not undergone endoscopy for more than 1 year
(4) Those who have requested to have the findings of ABC screening and recommendation for endoscopy through the telemedicine consultation
(5) Those who can undergo endoscopy at Fukushima Medical University Aizu Medical Center in principle when a full examination is required in this study
Key exclusion criteria
(1) Pregnant women
(2) Those with drug dependence or psychiatric disorders
(3) Those with stomach or other digestive system symptoms
(4) Patients under treatment for gastric diseases (gastric ulcer, duodenal ulcer, reflux esophagitis, etc.)
(5) Those who have had their stomach removed
(6) Those with renal failure
(7) Patients who have undergone eradication treatment for Helicobacter pylori
(8) Those who are participating in other clinical trials
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Tadayuki |
| Middle name | |
| Last name | Takagi |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
969-3492
Address
21-2 Yazawa Aza Maeda, Kawahigashi-machi, Aizuwakamatu-city, Fukushima, Japan
TEL
0242-75-2100
daccho@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
Fukushima Medical University
Division name
Department of Digital Health Services Research
Zip code
960-1295
Address
1 Hikariga-oka, Fukushima City, JAPAN
TEL
024-547-1206
Homepage URL
jyatabe@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Olympus Medical Systems co. ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fukushima Medical University
Address
1 Hikariga-oka, Fukushima City, JAPAN
Tel
024-547-1825
rs@fmu.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
| 2025 | Year | 04 | Month | 28 | 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
| 2024 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065929
