UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060759 |
|---|---|
| Receipt number | R000069518 |
| Scientific Title | A multicenter study to explore the appropriate interval between upper gastrointestinal endoscopies to effectively prevent gastric invasive cancer using the JED-project |
| Date of disclosure of the study information | 2026/02/26 |
| Last modified on | 2026/02/26 16:58:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multicenter study to explore the appropriate interval between upper gastrointestinal endoscopies to effectively prevent gastric invasive cancer
using the JED-project
Acronym
JED-INTERVAL Study
Scientific Title
A multicenter study to explore the appropriate interval between upper gastrointestinal endoscopies to effectively prevent gastric invasive cancer
using the JED-project
Scientific Title:Acronym
A multicenter study to explore the appropriate interval between upper gastrointestinal endoscopies to effectively prevent gastric invasive cancer
using the JED-project
Region
| Japan |
Condition
Condition
Invasive gastric cancer (pT1b or deeper invasion)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the optimal interval between surveillance endoscopies for preventing the development of invasive gastric cancer (pT1b or deeper), using data from the JED project.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of invasive gastric cancer according to individual risk factors
Key secondary outcomes
Incidence of intramucosal carcinoma and high-grade dysplasia stratified by risk group
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
Patients aged 50 years or older who undergo upper gastrointestinal endoscopy at participating institutions.
Key exclusion criteria
(1) Patients who decline participation in the study through the opt-out process.
(2) Patients who are deemed inappropriate for inclusion as study participants by the investigators or the principal investigator.
Target sample size
16000
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Miyaoka |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka
TEL
0570-02-7777
t.kanemitsu93@gmail.com
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kanemitsu |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka
TEL
0570-02-7777
Homepage URL
t.kanemitsu93@gmail.com
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
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
Fukuoka University Ethics Review Board
Address
7-45-1 Nanakuma, Jonan Ward, Fukuoka City, Fukuoka
Tel
092-801-1011
fumed-ethics@fukuoka-u.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
福岡大学筑紫病院、尾田胃腸内科・内科、服部胃腸科
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069518
