UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057408 |
|---|---|
| Receipt number | R000065595 |
| Scientific Title | A Multicenter Randomized Open-Label Study evaluating AI-powered applications for dietary intake in gastric cancer patients who receive curative treatment |
| Date of disclosure of the study information | 2025/03/26 |
| Last modified on | 2025/03/26 15:38:05 |
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Basic information
Public title
A Multicenter Randomized Open-Label Study evaluating AI-powered applications for dietary intake in gastric cancer patients who receive curative treatment
Acronym
A Multicenter Randomized Open-Label Study evaluating AI-powered applications for dietary intake in gastric cancer patients who receive curative treatment
Scientific Title
A Multicenter Randomized Open-Label Study evaluating AI-powered applications for dietary intake in gastric cancer patients who receive curative treatment
Scientific Title:Acronym
A Multicenter Randomized Open-Label Study evaluating AI-powered applications for dietary intake in gastric cancer patients who receive curative treatment
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This randomized controlled trial evaluates AI-powered applications for dietary intake and confirmed usefulness and improve the dietary intake and QOL after gastrectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was changes QOL score using Short Form-36 Health Survey (SF-36) during 4 weeks after registration.
Key secondary outcomes
The secondary endpoints were changes of oral dietary intake, body composition changes, and laboratory data during 4 weeks after registration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AI-powered applications support
Interventions/Control_2
no AI-powered applications support
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. age 18 years and over
2. patients who have undergone radical resection for gastric cancer
3. patients who can cook at home and take food orally after being discharged from hospital.
4. the patient must be able to access the internet environment and own a device that can use this website.
5. the patient's written consent to participate in the study has been obtained.
Key exclusion criteria
1.Patient who do not have access to the Internet environment or do not have a device capable of using the Site.
2.Patients who are unable to use the Site due to cognitive or physical impairment or disability.
3.Patients who do not have access to a cooking environment at home or who are unable to take food orally.
4.Patients who are already using ReTabell at the time of registration or have withdrawn their consent to the Terms of Use and Agreement.
5.Patients deemed inappropriate for inclusion in the study by the principal investigator or co-principal investigator.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Aoyama |
| Middle name | |
| Last name | Toru |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
2360004
Address
3-9 Fukuura Kanazawa0ku Yokohama
TEL
0457872800
t-aoyama@lilac.plala.or.jp
Public contact
Name of contact person
| 1st name | Hashimoto |
| Middle name | |
| Last name | Itaru |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
236-0004
Address
3-9 Fukuura Kanazawa0ku Yokohama
TEL
0457972800
Homepage URL
itarum1n1@hotmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9 Fukuura kanazawa-ku Yokohama
Tel
0457872800
rinri@yokohama-cu.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 | 03 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065595
