UMIN-CTR Clinical Trial

Basic information
Public title	liver signal profiling and blood marker research for non-alcoholic fatty liver diseases
Acronym	liver signal profiling and blood marker research for non-alcoholic fatty liver diseases
Scientific Title	liver signal profiling and blood marker research for non-alcoholic fatty liver diseases
Scientific Title:Acronym	liver signal profiling and blood marker research for non-alcoholic fatty liver diseases
Region	Japan

Condition
Condition	nonalcoholic fatty liver diseases
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To elucidate the factors associated with pathogenesis and development of nonalcoholic steatohepatitis (NASH) by the profiling of liver and blood collected from nonalcoholic steatohepatitis (NAFLD) patients, furthermore to research the early diagnostic procedure of NASH and create a therapeutic medication for NASH.
Basic objectives2	Others
Basic objectives -Others	Diagnosis and treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Proceeding Genechip analysis, Methylation BeadChip analysis, and comprehensive analysis of miRNA for signal profiling in liver by using liver biopsy samples collected in each trial sites 2) Proceeding Proteomics analysis, metabolomics analysis, and comprehensive analysis of miRNA to research diagnostic markers for NASH by using blood samples collected in each trial sites
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with suspected NAFLD by interview, blood collection, imaging studies
Key exclusion criteria	1) Persons over 20g per day or 140g per week of alcohol intake 2) Patients who are suspicious of viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, hemochromatosis, alpha1-antitrypsin deficiency, Wilson's disease, drug-induced hepatitis 3) Patients who showed clinical evidence of hepatic decompensation such as hepatic encephalopathy, ascites, variceal bleeding, or a serum bilirubin level greater than twofold the normal upper limit 4) Persons judged inappropriate for this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yuichiro Middle name Last name Eguchi
Organization	Saga University Hospital
Division name	Division of Hepatology
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga 849-8501, Japan
TEL	0952-34-3010
Email	eguchiyu@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Yuichiro Middle name Last name Eguchi
Organization	Saga University Hospital
Division name	Division of Hepatology
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga 849-8501, Japan
TEL	0952-34-3010
Homepage URL
Email	eguchiyu@cc.saga-u.ac.jp

Sponsor
Institute	Saga Medical School Hiroshima University Yokohama City University Graduate School of Medicine Takeda Pharmaceutical Company
Institute
Department

Funding Source
Organization	Saga Uiversity
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saga Uiversity
Address	5-1-1 Nabeshima, Saga 849-8501, Japan
Tel	0952-34-3010
Email	eguchiyu@cc.saga-u.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	佐賀大学病院（佐賀県）、広島大学病院（広島県）、横浜市立大学病院（神奈川県）、武田薬品工業株式会社（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 04 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	2013 Year 10 Month 01 Day
Date of IRB	2013 Year 10 Month 25 Day
Anticipated trial start date	2014 Year 02 Month 28 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is observational study. Samples are collected from patients with suspected NAFLD by interview, blood collection, imaging studies. In some cases, samples are collected two or more times from the same person. Analysis is conducted prospectively with the samples collected after the date of registration.

Management information
Registered date	2014 Year 03 Month 04 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015547