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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010659
Receipt No. R000012469
Scientific Title The assessment of surrogate marker for diagnosing nonalcoholic steatohepatitis
Date of disclosure of the study information 2013/05/09
Last modified on 2019/09/19

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Basic information
Public title The assessment of surrogate marker for diagnosing nonalcoholic steatohepatitis
Acronym Surrogate marker for diagnosing NASH
Scientific Title The assessment of surrogate marker for diagnosing nonalcoholic steatohepatitis
Scientific Title:Acronym Surrogate marker for diagnosing NASH
Region
Japan

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

Objectives
Narrative objectives1 To clarify the surrogate marker for diagnosing nonalcoholic steatohepatitis using the blood chemistry analysis and the imaging modalities, and to validate the usefulness of the new surrogate marker for outpatients
Basic objectives2 Others
Basic objectives -Others usefulness
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Examination of the surrogate marker for diagnosing nonalcoholic steatohepatitis
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Written informed concent is required.
2) more than 20 years-old
Key exclusion criteria 1) consumption of more than 20 g/day of alcohol
2) testing positive for HBs-Ag
3) demonstrating evidence of liver disease other than viral hepatitis, such as autoimmune hepatitis or primary biliary cirrhosis
4) no evidence of decompensated liver cirrhosis
5) pregnant and nursing woman
Target sample size 720

Research contact person
Name of lead principal investigator
1st name Teruki
Middle name
Last name Teruki
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code 7910295
Address Toon City, Ehime, Japan
TEL 0899605308
Email teruki-ygc@umin.ac.jp

Public contact
Name of contact person
1st name Teruki
Middle name
Last name Teruki Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code 7910295
Address Shitsukawa, Toon city, Ehime
TEL 0899605308
Homepage URL
Email teruki-ygc@umin.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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 The Ethics Committee of Ehime University Hospital
Address Toon Ehime
Tel +81899605308
Email teruki-ygc@umin.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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 09 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
2010 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study
examination of surrogate marker for diagnosing nonalcoholic steatohepatitis

Management information
Registered date
2013 Year 05 Month 07 Day
Last modified on
2019 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012469

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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