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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030222
Receipt No. R000034523
Scientific Title The examination of predictive factors and prognosis in nonalcoholic steatohepatitis
Date of disclosure of the study information 2017/12/01
Last modified on 2017/12/01

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Basic information
Public title The examination of predictive factors and prognosis in nonalcoholic steatohepatitis
Acronym The examination of predictive factors and prognosis in NASH
Scientific Title The examination of predictive factors and prognosis in nonalcoholic steatohepatitis
Scientific Title:Acronym The examination of predictive factors and prognosis in NASH
Region
Japan

Condition
Condition Nonalcoholic steatohepatitis (NASH)
Nonalcoholic fatty liver disease (NAFLD)
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to identify the associated factor of NASH using computed tomography, abdominal ultrasonography, blood test, and liver tissue. Additionally, we explore the prognosis of NAFLD. Finally, we investigated the risk factor for progression of NAFLD, metabolic diseases, and atherosclerotic diseases.
Basic objectives2 Others
Basic objectives -Others Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Investigate the associated factors for NASH
Explore the predictive factors with prognosis of NAFLD
Key secondary outcomes Identify the associated factors with histological fibrosis in the liver
Identify the associated factors with histological fat droplets in the liver
Identify the associated factors with histological inflammation in the liver
Identify the associated factors with the severity of fibrosis and steatosis in the liver assessed by the ultrasonography
Explore the predictive factors for progression of fibrosis in the liver
Explore the predictive factors for onset of complication of liver
Explore the predictive factors for onset of metabolic diseases
Explore the predictive factors for onset of atherosclerotic diseases

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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Male and female over twenty years of age
Biopsy-proven NAFLD patients
Key exclusion criteria Patients with pregnancy and lactation
Patients with poor condition
Persons judged inappropriate for this study
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruki Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Toon City, Ehime, Japan
TEL +81899605308
Email teruki-ygc@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruki Miyake
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Toon city, Ehime
TEL +81899605308
Homepage URL
Email teruki-ygc@umin.ac.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Self funding
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
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
2017 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
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
2017 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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 The aim of this study is to identify the associated factor of NASH using computed tomography, abdominal ultrasonography, blood test, and liver tissue. Additionally, we explore the prognosis of NAFLD. Finally, we investigated the risk factor for progression of NAFLD, metabolic diseases, and atherosclerotic diseases.

Management information
Registered date
2017 Year 12 Month 01 Day
Last modified on
2017 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034523

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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