UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014850 |
|---|---|
| Receipt number | R000017259 |
| 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 |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2020/08/17 05:18:37 |
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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
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
fwix0777@nifty.com
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017259
