UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051625 |
|---|---|
| Receipt number | R000058905 |
| Scientific Title | Registry study on the prognosis of fatty liver patients undergoing liver stiffness measurement |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/09/02 08:24:48 |
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Basic information
Public title
Registry study on the prognosis of fatty liver patients undergoing liver stiffness measurement
Acronym
Prognostic studies of fatty liver patients
Scientific Title
Registry study on the prognosis of fatty liver patients undergoing liver stiffness measurement
Scientific Title:Acronym
Prognostic studies of fatty liver patients
Region
| Japan |
Condition
Condition
fatty liver
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of complications and their medications on life expectancy in fatty liver patients undergoing liver stiffness measurement in a multicenter registry study
Basic objectives2
Others
Basic objectives -Others
nothing in particular
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether all-cause mortality increases with higher LSM
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. suspected fatty liver since January 2012 and underwent the first liver hardness test (Fibroscan)
2. be at least 20 years of age at the time of the first liver hardness test (at the time of obtaining consent).
Key exclusion criteria
1. patients who are judged by the investigator to be unsuitable for inclusion in the study
2. patients who refuse to participate in the study
3. patients suspected of having other chronic liver diseases.
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Toyoda |
Organization
Ogaki Municipal Hospital
Division name
Department of Gastroenterology
Zip code
503-8502
Address
4-86, Minami-Cheek-cho, Ogaki-shi, Gifu
TEL
0584813341
hmtoyoda@spice.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Fujii |
Organization
Graduate School of Medicine, Osaka Metropolitan University
Division name
Department of Hepatology
Zip code
545-8585
Address
1-4-3 Asahi-cho, Abeno-ku, Osaka City
TEL
(06)6645-3905
Homepage URL
fujiirola@yahoo.co.jp
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
no
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
Ogaki Municipal Hospital Clinical Research Review Committee
Address
4-86, Minami-Cheek-cho, Ogaki-shi, Gifu
Tel
(0584) 81-3341
hmtoyoda@spice.ocn.ne.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
| 2023 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter registry study.
Management information
Registered date
| 2023 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058905
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
