UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013323 |
|---|---|
| Receipt number | R000015547 |
| Scientific Title | liver signal profiling and blood marker research for non-alcoholic fatty liver diseases |
| Date of disclosure of the study information | 2014/03/04 |
| Last modified on | 2020/10/09 09:09:34 |
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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
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
eguchiyu@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga Medical School
Hiroshima University
Yokohama City University Graduate School of Medicine
Takeda Pharmaceutical Company
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015547
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
