UMIN-CTR Clinical Trial

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 Masanori Middle name Last name Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code	270-1196
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 Masanori Middle name Last name Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code	2701613
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	Nippon Medical School Chiba Hokousoh Hospital
Address	1715 Kamagari Inzai Chiba
Tel	+81476991111
Email	araraki@nms.ac.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	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	2021 Year 06 Month 23 Day

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