UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050414 |
|---|---|
| Receipt number | R000057404 |
| Scientific Title | Identification of fibrosis-promoting factors using magnetic resonance elastography (MRE) and proton density fat fraction (PDFF) in nonalcoholic fatty liver disease (NAFLD) |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2024/08/24 16:32:24 |
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Basic information
Public title
Identification of fibrosis-promoting factors using magnetic resonance elastography (MRE) and proton density fat fraction (PDFF) in nonalcoholic fatty liver disease (NAFLD)
Acronym
Liver fibrosis and hepatic steatosis
Scientific Title
Identification of fibrosis-promoting factors using magnetic resonance elastography (MRE) and proton density fat fraction (PDFF) in nonalcoholic fatty liver disease (NAFLD)
Scientific Title:Acronym
Identification of Fibrosis-Promoting Factors in NAFLD
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Liver fibrosis is considered a prognostic factor in nonalcoholic fatty liver disease (NAFLD). However, the factors involved in the development of liver fibrosis remain unclear. We aim to clarify these factors using quantitative magnetic resonance imaging (quantitative MRI), which has made remarkable progress in recent years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the relationship between the degree of hepatic steatosis and the rate of 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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients with NAFLD for which viral, autoimmune, or alcoholic causes have been ruled out.
(ii) Patients with MRE and MRI-PDFF taken more than 2 years after the first MRE and MRI-PDFF measurement. However, for patients with multiple MRE and MRI-PDFF imaging, the MRE and MRI-PDFF values after 2 years shall be used. For patients who are currently under observation and have not had MRE and MRI-PDFF after an interval of 2 years, MRE and MRI-PDFF will be newly obtained after obtaining consent.
(iii) Patients whose participation is deemed appropriate by the principal investigator or subinvestigator.
Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria
(1) Patients with claustrophobia
(2) Patients with magnetic materials or tattoos on the body (3) Patients with a pacemaker
(3) Patients with a pacemaker
(iv) Patients who are judged by the principal investigator or subinvestigator to be unsuitable for the study.
Target sample size
500
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-shi, Gifu-ken
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
Department of Nursing, Faculty of Nursing
Zip code
503-8550
Address
5-50, Kitagata-cho, Ogaki-shi, Gifu-ken
TEL
+819014740074
Homepage URL
takashi.kumada@gmail.com
Sponsor or person
Institute
Nayoro City General Hospital
Suita Municipal Hospital
Tokyo Medical University
Iwate Medical University
Aichi Medical University of Medicine
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
+81584813341
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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38558221/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38558221/
Number of participants that the trial has enrolled
471
Results
471 patients were enrolled. factors associated with LSM progression were steatosis grade 3 and albumin-bilirubin grade 2 or 3. the only factor associated with LSM regression was the rate of decrease in MRI-PDFF. LSM stage 0 (<2.5 kPa) In patients, adiposity grade 3 correlated with a higher incidence of LSM progression than adiposity grade 1 (MRI-PDFF < 11.3%), and in patients with LSM 1 or 2-4, an annual decrease in MRI-PDFF of 5% or more than 5% of the correlated with a higher incidence of LSM regression.
Results date posted
| 2024 | Year | 04 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We retrospectively analysed patients with MASLD who underwent at least two serial MRE and magnetic resonance imaging-based proton density fat fraction (MRI-PDFF) examinations at least 1 year apart. Fine-Gray competitive proportional hazard regression was used to identify LSM progression and regression factors.
Participant flow
he predictors of progression from steatosis to more advanced stages of metabolic dysfunction-associated steatotic liver disease (MASLD) remain unclear. We evaluated the association between the quantity of hepatic steatosis and longitudinal changes in liver stiffness measurements (LSMs) using magnetic resonance elastography (MRE) in patients with MASLD.
Adverse events
None
Outcome measures
Severe hepatic steatosis was linked to significant LSM progression in patients with MASLD and low LSM (<2.5 kPa).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Retrospective Study
Management information
Registered date
| 2023 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057404
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/08/24 | 量的MRIの同意文書(第1.1版).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/08/24 | 多施設データ入力用.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/08/24 | Database.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/57404
