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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035188
Receipt No. 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 2019/04/11

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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
Email 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
Email yuji.ogawa01@gmail.com

Sponsor
Institute Yokohama City University
Institute
Department

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
Email 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)
イムス札幌消化器中央総合病院(北海道)
群馬県済生会前橋病院(群馬県)
国立国際医療センター病院(東京都)
船橋中央病院(千葉県)
JCHO横浜中央病院(神奈川県)
神奈川歯科大学横浜クリニック(神奈川県)
福井済生会病院(福井県)
福知山市民病院(京都府)
JA広島総合病院(広島県)
江口病院(佐賀県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 09 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 Open public recruiting
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
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 06 Month 30 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
2019 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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