UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive Analysis of Disease-Related Genes associated with Non-alcoholic Fatty Liver Disease (NAFLD)/ Non-Alcoholic Steatohepatitis (NASH); Study of Associations among the Disease-Related Genes and Serum Biomarkers and the Degree of Progression of NAFLD/NASH Pathology
Acronym	Comprehensive Analysis of Disease-Related Genes associated with NAFLD/NASH; Study of Associations among the Disease-Related Genes and Serum Biomarkers and the Degree of Progression of NAFLD/NASH Pathology
Scientific Title	Comprehensive Analysis of Disease-Related Genes associated with Non-alcoholic Fatty Liver Disease (NAFLD)/ Non-Alcoholic Steatohepatitis (NASH); Study of Associations among the Disease-Related Genes and Serum Biomarkers and the Degree of Progression of NAFLD/NASH Pathology
Scientific Title:Acronym	Comprehensive Analysis of Disease-Related Genes associated with NAFLD/NASH; Study of Associations among the Disease-Related Genes and Serum Biomarkers and the Degree of Progression of NAFLD/NASH Pathology
Region	Japan

Condition
Condition	Non-alcoholic Fatty Liver Disease/ Non-alcoholic Steatohepatitis
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism Radiology Laboratory medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We will explore associations among the NAFLD/NASH- related genes, degree of pathological progression in the liver of NAFLD patients, serum markers and several factors associated with lipid metabolism in the liver.
Basic objectives2	Others
Basic objectives -Others	We will explore associations among the NAFLD/NASH- related genes, degree of pathological progression in the liver of NAFLD patients, serum markers and several factors associated with lipid metabolism in the liver.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	We will conduct this study by performing comprehensive analysis of genes in NAFLD patients grouped according to the degree of histopathological progression in the liver and detect the genetic modifiers of NAFLD/NASH pathogenesis.
Key secondary outcomes	We will comprehensively analyze each factor involved in fatty acid metabolism in each group by using blood serum and liver tissue collected. Then we assess their relationships with the genetic modifiers of NAFLD/NASH pathogenesis.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	We will perform liver biopsy.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	NAFLD patients -Patients with a pathological diagnosis of NAFLD based on a liver biopsy Patients from whom consent has been obtained to participate in this study, which has been approved by the ethics committee.
Key exclusion criteria	a. Patients who have any other liver disease, such as chronic hepatitis C, chronic hepatitis B (HBs-Ag-positive patients), autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, alpha 1-antitrypsin deficiency, Wilson disease, or alcohol-related liver disease b. Patients who have a serious hepatic dysfunction, liver failure (encephalopathy, ascites, ruptured varices, or hyperbilirubinemia) c. Patients who have a serious renal dysfunction d. Patients who have a serious cardiopulmonary dysfunction e. Pregnant women, parturient women, breast-feeding women
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Nozaki
Organization	National Center for Global Health and Medicine
Division name	Department of Gastroenterology
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Email	fwix0777@nifty.com

Public contact
Name of contact person	1st name Yuichi Middle name Last name Nozaki
Organization	National Center for Global Health and Medicine
Division name	Department of Gastroenterology
Zip code	162-8655
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	fwix0777@nifty.com

Sponsor
Institute	National Center for Global Health and Medicine, Department of Gastroenterology Kohnodai Hospital, Department of Gastroenterology The Research Center for Hepatitis and Immunology
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Yokohama City University School of Medicine, Department of Gastroenterology and Hepatology Tokyo Medical University, Department of Gastroenterology and Hepatology
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional review board, National Center for Global Health and Medicine
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel	03-3202-7181
Email	rinrijm@hosp.ncgm.go.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	国立国際医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 01 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	308
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	No longer recruiting
Date of protocol fixation	2014 Year 03 Month 17 Day
Date of IRB	2014 Year 03 Month 17 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 12 Day
Last modified on	2020 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017259