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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015575
Receipt No. R000018102
Scientific Title Analysis of exosomal miRNA expression in non-alcoholic fatty liver disease (NAFLD)
Date of disclosure of the study information 2014/11/04
Last modified on 2014/10/31

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Basic information
Public title Analysis of exosomal miRNA expression in non-alcoholic fatty liver disease (NAFLD)
Acronym miRNA expression analysis in NAFLD
Scientific Title Analysis of exosomal miRNA expression in non-alcoholic fatty liver disease (NAFLD)
Scientific Title:Acronym miRNA expression analysis in NAFLD
Region
Japan

Condition
Condition non-alcoholic fatty liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 in order to develop the simple method for NASH diagnosis
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 80% or more of diagnostic performance is obtained.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria It is diagnosed as the fatty liver with the abdominal ultrasonography.
The consent of a liver biopsy is obtained.
NAFLD or NASH is diagnosed by the histological examination.
Key exclusion criteria the persons who take alcohol routinely
HBV, HCV, or HIV infection
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Murakami
Organization Graduate school of medicine, Osaka city university
Division name Department of hepatology
Zip code
Address 1-4-3, asahimachi, abenoku, Osaka
TEL 81-6-6645-3811
Email m2079633@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Fujii
Organization Osaka city juso hospital
Division name Department of gastroenterology
Zip code
Address 2-12-27, nonakakita, yodogawaku, Osaka
TEL 81-6-6151-8000
Homepage URL
Email rolahideki@med.osaka-cu.ac.jp

Sponsor
Institute Osaka city university
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2014 Year 11 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 Preinitiation
Date of protocol fixation
2014 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information unpublished

Management information
Registered date
2014 Year 10 Month 31 Day
Last modified on
2014 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018102

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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