UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057036 |
|---|---|
| Receipt number | R000064579 |
| Scientific Title | Clinical research on the development of patient exploration tools for patients suspected of Fabry disease in the medical checkup support app |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/10/03 16:40:43 |
* 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
Clinical research on the development of patient exploration tools for patients suspected of Fabry disease in the medical checkup support app
Acronym
Clinical research on the development of patient exploration tools for patients suspected of Fabry disease in the medical checkup support app
Scientific Title
Clinical research on the development of patient exploration tools for patients suspected of Fabry disease in the medical checkup support app
Scientific Title:Acronym
Clinical research on the development of patient exploration tools for patients suspected of Fabry disease in the medical checkup support app
Region
| Japan |
Condition
Condition
Fabry disease
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Nephrology | Neurology | Ophthalmology |
| Radiology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing patient search tools using information such as health examinations managed in the medical checkup support app, leading to early diagnosis of Fabry disease and the start of early treatment.
Basic objectives2
Others
Basic objectives -Others
Conduct a pilot study to develop a tool to identify patients with Fabry disease among people who have undergone health checkups at health checkup centers in Tokyo.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The CARADA medical examination support app is a medical examination support app developed by MTI Co., Ltd.
The conversion rate (transition rate, action rate) of subjects at each user touch point for the search tool set up in this app to detect suspected patients with Fabry disease will be evaluated as follows.
1.Participation rate (consent rate) of this clinical study among all patients referred to this clinical study
2.The following behaviors of study subjects who are judged to be suspected of having Fabry disease
2-1.Consultation rate at the consultation desk when screening results are reported
2-2.Appointment rate of specialist medical institutions after reporting screening results
3.Response rate of questionnaires conducted for all study subjects
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who receive a health checkup after April 2025 at one facility at the medical examination center in Tokyo.
Those who have registered for the CARADA medical check-up support app and are using their own smartphones to manage their health through medical check-up data
Those who have the consent of providing their own data in the CARADA medical examination support app for participation in this clinical research and participation to the research institution
Key exclusion criteria
Those under 18 years old
Those who are judged by the research responsibility or co-investigator to be inappropriate as a research subject for the research
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Ieda |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
roroyama@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamakawa |
Organization
Keio University Hosital
Division name
Center For Preventive Medicine
Zip code
106-0041
Address
Azabudai Hills Mori JP Tower, 5th floor,1-3-1 Azabudai, Minato-ku, Tokyo
TEL
03-6910-3533
Homepage URL
roroyama@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare, Health, Labor and Welfare Research Aid
Interact Diseases Policy Research Projec
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35, Shinanomachi, Shinjuku, Tokyo
Tel
03-3353-1211
keio@esct.bvits.com
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 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Participation rate (consent rate) of this clinical study among all patients referred to this clinical study
2.The following behaviors of study subjects who are judged to be suspected of having Fabry disease
2-1.Consultation rate at the consultation desk when screening results are reported
2-2.Appointment rate of specialist medical institutions after reporting screening results
3.Response rate of questionnaires conducted for all study subjects
Management information
Registered date
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064579
