UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059239 |
|---|---|
| Receipt number | R000057648 |
| Scientific Title | Development of telemedicine services with a home-based test and the utility evaluation |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/30 15:19:10 |
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Basic information
Public title
Development of telemedicine services with a home-based test and the utility evaluation
Acronym
Development and evaluation of telemedicine services with a home-based test
Scientific Title
Development of telemedicine services with a home-based test and the utility evaluation
Scientific Title:Acronym
Development of telemedicine services with a home-based test and the utility evaluation
Region
| Japan |
Condition
Condition
Patients with gastroenterological diseases
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By collaborating with local visiting nursing stations, we have developed a scheme in which specimens are collected outside the hospital up to the day before regular attendance, and the test results are obtained by the attending physician the day before or before outpatient treatment, which also serves as a background check for the patient. and verify its usefulness in terms of patient comfort and QOL.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient clinical information, patient convenience and satisfaction survey results
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A visiting nurse will collect blood samples from the research subject's home up to the day before the outpatient treatment or at a visiting nursing station to obtain a blood sample and a urine sample collected by the patient himself/herself.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Persons over 20 years old
- Digestive system cancer patient undergoing chemotherapy or periodic laboratory tests during post-operative follow-up at Minoh City Hospital
- Those who have given written consent for research participation
Key exclusion criteria
- Person lacking the capacity to consent
- Persons judged to be inappropriate for study participation by the principal investigator or sub-physician (hereinafter referred to as principal investigator, etc.)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Norikatsu |
| Middle name | |
| Last name | Miyoshi |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2 Yamadaoka, Suita, Osaka
TEL
06-6879-3251
nmiyoshi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Norikatsu |
| Middle name | |
| Last name | Miyoshi |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2 Yamadaoka, Suita, Osaka
TEL
06-6879-3251
Homepage URL
nmiyoshi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Norikatsu Miyoshi
Funding Source
Organization
SYSMEX CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Minoh City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6879-5111
rinri@hp-crc.med.osaka-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
箕面市立病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 30 | 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
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2027 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057648
