UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053755 |
|---|---|
| Receipt number | R000061342 |
| Scientific Title | Long-term prognosis of Steatotic Liver Disease (SLD) using quantitative magnetic resonance imaging (quantitative MRI) |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/03/01 18:54:41 |
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Basic information
Public title
Long-term prognosis of Steatotic Liver Disease (SLD) using quantitative magnetic resonance imaging (quantitative MRI)
Acronym
SLD and quantitative MRI
Scientific Title
Long-term prognosis of Steatotic Liver Disease (SLD) using quantitative magnetic resonance imaging (quantitative MRI)
Scientific Title:Acronym
Long-term prognosis of Steatotic Liver Disease
Region
| Japan |
Condition
Condition
Steatotic Liver Disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, the name of non-alcoholic fatty liver disease (NAFLD) has been changed to fatty liver disease (SLD) and metabolic abnormality-related fatty liver disease (MASLD). The purpose of this study was to analyze liver stiffness (liver fibrosis) and hepatic steatosis over time using quantitative magnetic resonance imaging (quantitative MRI) to identify factors involved in the course and prognosis (cause of death, complications, etc.) of this newly proposed classification of disease. and prognosis (cause of death, complications, etc.).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver stiffness (liver fibrosis), the factor most strongly related to prognosis, was used as the objective variable to analyze how the degree and change of hepatic steatois and other factors are related to the progression of liver fibrosis.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1,Patients with SLD in which hepatitis C, hereditary, drug-related, or other associations have been ruled out. However, patients with SLD associated with hepatitis B, autoimmune hepatitis, and primary biliary cirrhosis shall be eligible.
2,Patients with SLD associated with hepatitis B, autoimmune hepatitis, or primary biliary cirrhosis are eligible. Patients who are currently under observation and have not had a quantitative MRI after an interval of at least one year are also included, as are patients who have obtained a new consent form and had a quantitative MRI after an interval of at least one year.
3,Patients without concurrent hepatocellular carcinoma at the time of the first quantitative MRI. However, patients who subsequently developed hepatocellular carcinoma will be included if more than one year has passed since the first quantitative MRI and the interval between the second (or more than one) quantitative MRI measurement and the first quantitative MRI measurement is more than one year.
4,Patients whose participation is deemed appropriate by the principal investigator or subinvestigator.
Key exclusion criteria
1,Patients with claustrophobia
2,Patients with magnetic materials or tattoos on the body
3,Patients with a pacemaker
4,Patients who are judged by the principal investigator or subinvestigator to be unsuitable for the study.
Target sample size
1000
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 and Hepatology
Zip code
5038502
Address
4-86, Minaminokawa-cho, Ogaki, Gifu.
TEL
+81584813341
hmtoyoda@spice.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kumada |
Organization
Gifu Kyoritsu University
Division name
Faculty of Nursing
Zip code
500-8550
Address
5-50, Kitagata-cho, Ogaki, Gifu
TEL
0584773511
Homepage URL
takashi.kumada@gmail.com
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogaki Municipal Hospital
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
Address
4-86 Minaminokawa, Ogaki, Gifu, Japan, 503-8502
Tel
+81-584-81-3341
clinical-trial@omh.ogaki.gifu.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
| 2024 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Retrospective study
Management information
Registered date
| 2024 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061342
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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