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

Email

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


Email

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name