UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030222 |
|---|---|
| Receipt number | 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 | 2021/12/19 11:53:37 |
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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 | Teruki |
| Middle name | |
| Last name | Miyake |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Toon City, Ehime, Japan
TEL
+81899605308
teruki-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Teruki |
| Middle name | |
| Last name | Miyake |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Toon city, Ehime
TEL
+81899605308
Homepage URL
teruki-ygc@umin.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
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
The Ethics Committee of Ehime University Hospital
Address
Toon Ehime
Tel
+81899605914
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
| 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
| 2017 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
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
| 2021 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034523
