UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035188 |
|---|---|
| Receipt number | R000039142 |
| Scientific Title | Multicenter, prospective research on prevalence and fibrosis stage distribution in Japanese NAFLD patients using with ultrasound elastography [FibroScan] and Fib4 index |
| Date of disclosure of the study information | 2018/12/09 |
| Last modified on | 2025/07/29 00:20:05 |
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Basic information
Public title
Multicenter, prospective research on prevalence and fibrosis stage distribution in Japanese NAFLD patients using with ultrasound elastography [FibroScan] and Fib4 index
Acronym
Multicenter, prospective research on prevalence and fibrosis stage distribution in Japanese NAFLD patients using with ultrasound elastography [FibroScan] and Fib4 index
Scientific Title
Multicenter, prospective research on prevalence and fibrosis stage distribution in Japanese NAFLD patients using with ultrasound elastography [FibroScan] and Fib4 index
Scientific Title:Acronym
Multicenter, prospective research on prevalence and fibrosis stage distribution in Japanese NAFLD patients using with ultrasound elastography [FibroScan] and Fib4 index
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease (NAFLD)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the prevalence and elucidate the distribution of fibrosis stage in JAPANESE NAFLD patients.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the prevalence of NAFLD among people who receive a health checkup and elucidate the distribution of fibrosis stage in NAFLD patients by FibroScan
Key secondary outcomes
1. To determine the proportion of patients with advanced fibrosis among NAFLD patients with a Fib4 index of <1.3
2. To determine how to set appropriate cutoff values of Fib4 index for each age category
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People who will receive a health checkup with abdominal US
Key exclusion criteria
1. Alcohol consumption (ethanol equivalent volume), >=30 g/day for men, >=20 g/day for women, or >=210 g/day for men, >=140 g/day for women.
2. History of chronic hepatic disease (hemochromatosis, viral hepatic disease [hepatitis B or C], or autoimmune disease,[autoimmune hepatitis, primary biliary cholangitis]), thyroid disorder, lipoatrophy, parenteral nutrition, abetalipoproteinemia, alpha-1-antitrypsin deficiency, Wilson's disease, antiretroviral therapy, Reye's syndrome, HELLP syndrome, or inborn errors of metabolism (lecithin-cholesterol acyltransferase deficiency or lysosomal acid lipase deficiency)
3. Drug-induced liver disorder (amiodarone, methotrexate, tamoxifen, corticosteroids, valproic acid, and antiretroviral drugs)
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Ogawa |
Organization
Medical school
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawaku, Yokohama , Japan
TEL
045-787-2800
yuji.ogawa01@gmail.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Ogawa |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawaku, Yokohama , Japan
TEL
045-787-2800
Homepage URL
yuji.ogawa01@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Gilead Sciences Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
United States of America
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9 Fukuura, Kanazawaku, Yokohama , Japan
Tel
0457872800
yuji.ogawa01@gmail.com
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
JCHO北海道病院（北海道）
群馬済生会前橋病院（群馬県）
国立国際医療センター病院（東京都）
キッコーマン総合病院（千葉県）
船橋中央病院（千葉県）
JCHO横浜中央病院（神奈川県）
神奈川歯科大学附属横浜クリニック（神奈川県）
新百合ヶ丘総合病院（神奈川県）
国際医療福祉大学熱海病院（静岡県）
福井済生会病院（福井県）
津島市民病院（愛知県）
安城更生病院（愛知県）
名古屋大学大学院医学系研究科（愛知県）
川崎医科大学総合医療センター（岡山県）
JA広島総合病院（広島県）
島根大学医学部付属病院（島根県）
ヘルスサイエンスセンター島根（島根県）
香川大学医学部付属病院（香川県）
KKR高松病院（香川県）
朝倉医師会病院（福岡県）
長崎みなとメディカルセンター（長崎県）
佐賀大学医学部附属病院（佐賀県）
江口病院（佐賀県）
鹿児島厚生連病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/hepr.14117
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/hepr.14117
Number of participants that the trial has enrolled
6530
Results
Acknowledging the selection bias in hepatology centers, we undertook this prospective health check-up study. Although the FIB-4 index proves to be a convenient marker, it might not perform well as a primary screening tool for liver fibrosis in the general population.
Results date posted
| 2025 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This cross-sectional prospective study consecutively enrolled subjects who underwent health check-ups including abdominal ultrasonography at 10 health promotion centers in Japan between July 2019 and March 2022. We identified 6530 subjects from the International University of Health and Welfare Atami Hospital, Kagoshima Kouseiren Hospital, JCHO Hokkaido Hospital, Asakura Medical Association Hospital, Tsushima City Hospital, Shin-yurigaoka General Hospital, KKR Takamatsu Hospital, Kikkoman General Hospital, Kawasaki Medical School General Medical Center, and Anjo Kosei hospital.
Participant flow
The history of alcohol intake was assessed by the questionnaire. All subjects underwent conventional B-mode ultrasound, following which, those with MASLD consecutively underwent VCTE. We excluded those with malignant neoplasms of the liver and/or intrahepatic bile ducts, primary biliary cholangitis, autoimmune hepatitis, and positive for hepatitis B surface antigen from the analysis. Steatotic liver disease was defined according to new consensus nomenclature as follows:
MASLD: steatosis (conventional B-mode ultrasound) + >=1 cardiometabolic criteria + average daily alcohol intake <20 g (women) or <30 g (men).
MetALD: steatosis (conventional B-mode ultrasound) + average daily alcohol intake >=20 g (women) or >=30 g (men).
ALD: steatosis (conventional B-mode ultrasound) + average daily alcohol intake >=50 g (women) or >=60 g (men).
Specific etiology or cryptogenic SLD: steatosis (conventional B-mode ultrasound) + no cardiometabolic criteria + average daily alcohol intake <20 g (women) or <30 g (men).
Specific etiologies included drug-induced liver injury, monogenic diseases (e.g., Wilson disease, inborn errors of metabolism), miscellaneous causes (e.g., hepatitis C virus, celiac disease), while cryptogenic reflected no identifiable cause.
Adverse events
Nothing
Outcome measures
The prevalence of SLD was 39.5%, comprising MASLD 28.7%, MetALD 8.6%, ALD 1.2%, specific etiology SLD 0.3%, and cryptogenic SLD 0.7%.
Subjects with VCTE-derived LSM >=8 kPa constituted 2.1% of MASLD. FIB-4 >=1.3 showed that the sensitivity, specificity, positive predictive value (PPV), and negative predictive value for diagnosing VCTE-derived LSM >=8 kPa were 60.6%, 77.0%, 5.3%,and 98.9%, respectively. The referral rate to specialists was 23.8% using FIB-4 >=1.30. "FIB-4 >=1.3 in subjects <65 years and FIB-4 >=2.0 in subjects >=65 years"showed higher PPV (6.7%) and lower referral rate (17.1%) compared with FIB-4 >=1.3, but the sensitivity (54.5%) did not show adequate diagnostic capability as a noninvasive test for diagnosing VCTE-derived LSM >=8 kPa.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Fib4 index can be measured within the scope of laboratory testing with a blood sample usually performed in a health checkup, and FibroScan is also a non-invasive test. Therefore, this research will not pose any risk to research subjects.
Management information
Registered date
| 2018 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039142
