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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023286
Receipt No. R000026830
Scientific Title Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease
Date of disclosure of the study information 2016/07/23
Last modified on 2016/07/22

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Basic information
Public title Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease
Acronym Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease
Scientific Title Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease
Scientific Title:Acronym Comparing several biomarkers to predict liver fibrosis in patients with nonalcoholic fatty liver disease
Region
Japan

Condition
Condition nonalcoholic fatty liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate which markers more accurately reflect the fibrosis stage in patients with nonalcoholic fatty liver disease
Basic objectives2 Others
Basic objectives -Others To evalute the values of sensitivity and specificity for various biomarkers in each fibrosis stage.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The values of AUC, sensitivity, specificity, PPV, and NPV for various biomarkers.
Correlation between serum fibrotic markers for predicting liver fibrosis.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1,Taking alcohol less than 20g/day for female and 30g/day for male respectively
2,patients diagnosed as NAFLD by liver biopsy

Key exclusion criteria 1,alcohol abuse (quantity of ethanol intake more than 20g/day for female and 30g/day for male respectively)
2,type 1 diabetes,
3,positive HBs antigen, HCV antibody, or HIV antibody,
4,other liver diseases, such as autoimmune hepatitis, primary biliary cirrhosis, and drug-induced liver disorder
5,being treated with oral vitamin E preparation and thiazolidinediones for NAFLD or other disorders
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Atsukawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code
Address 1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL 0476-99-1111
Email atsukawa-nms@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Atsukawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code
Address 1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL 0476-99-1111
Homepage URL
Email atsukawa-nms@umin.ac.jp

Sponsor
Institute Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization Nippon Medical School Chiba Hokusoh Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Center for Global Health and Medicine (NCGM)
Shinmatsudo Central General Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 日本医科大学千葉北総病院(千葉県)Nippon Medical School Chiba Hokusoh Hospital
国立国際医療研究センター(千葉県)National Center for Global Health and Medicine (NCGM)
新松戸中央総合病院(千葉県)Shinmatsudo Central General Hospital (Chiba)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 23 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
2016 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Comparison of liver fibrosis biomarkers in patients with NAFLD diagnosed by liver biopsy

Management information
Registered date
2016 Year 07 Month 22 Day
Last modified on
2016 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026830

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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