UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056726 |
|---|---|
| Receipt number | R000064448 |
| Scientific Title | Developing a micro-elimination model by promoting an effective medical network linkage to care between hepatologists and ophthalmologists |
| Date of disclosure of the study information | 2025/01/15 |
| Last modified on | 2025/01/15 21:56:13 |
* 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
Developing a micro-elimination model by promoting an effective medical network linkage to care between hepatologists and ophthalmologists
Acronym
Mie-LINK
Scientific Title
Developing a micro-elimination model by promoting an effective medical network linkage to care between hepatologists and ophthalmologists
Scientific Title:Acronym
Mie-LINK
Region
| Japan |
Condition
Condition
hepatitis C virus
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a linkage to care model for potential HCV patients in cooperation with ophthalmologists and hepatologists
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients who visited a specialist by mail or telephone among those who tested positive for HCV antibodies. but did not receive a thorough examination by hepatologist
Key secondary outcomes
The proportion of patients who undergo HCV-Ag as a preoperative test in the ophthalmological field, rate of positive HCV-Ag , patient characteristics of HCV-Ag positive HCV will be evaluated
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who tested positive for HCV-Ag test at the Department of Ophthalmology, those who have not been referred to a gastroenterologist or hepatologist, or patients who are lost to follow-up
Key exclusion criteria
Patients who were judged inadequate to participate by researchers
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Nakagawa |
Organization
Mie University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-232-1111
nakagawah@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Tameda |
Organization
Mie University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-232-1111
Homepage URL
tameda@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine
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
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174, Edobashi, Tsu, Mie
Tel
059-232-1111
kk-sien@med.mie-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 15 | 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 | 11 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2025 | Year | 01 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064448
