UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040830 |
|---|---|
| Receipt number | R000046612 |
| Scientific Title | Outcome of patients with chronic liver disease by US and MRI. |
| Date of disclosure of the study information | 2020/06/19 |
| Last modified on | 2023/06/22 09:19:50 |
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Basic information
Public title
Outcome of patients with chronic liver disease by US and MRI.
Acronym
Chronic liver disease and MRI/US
Scientific Title
Outcome of patients with chronic liver disease by US and MRI.
Scientific Title:Acronym
Chronic liver disease and MRI/US
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The present study is performed to evaluate the usefulness for diagnosis of fibrosis stage and impact for mortality and liver-related events.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Relationships between image findings and backgrounds.
2) Occurrence rates of liver-related events.
3) Overall mortality and liver-related mortality.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 20 years old and more
2) Patients are in Toranomon hospital or Toranomon branch hospital.
3) Patients are performed US and MRI.
4) Chronic liver disease.
Key exclusion criteria
Other than the above.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Saitoh |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
sa3110@f2.dion.ne.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Akuta |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
norioakuta@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Toranomon Hospital institutional review board
Address
Toranomon 2-2-2, Minato-ku, Tokyo
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
| 2020 | Year | 06 | Month | 19 | 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
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2020 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046612
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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