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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029177
Receipt No. R000033253
Scientific Title The evaluation of liver fibrosis by shear wave elastography in patients wit non-alcoholic steatohepatitis
Date of disclosure of the study information 2017/10/01
Last modified on 2019/09/30

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Basic information
Public title The evaluation of liver fibrosis by shear wave elastography in patients wit non-alcoholic steatohepatitis
Acronym Elastography and non-alcoholic steatohepatitis
Scientific Title The evaluation of liver fibrosis by shear wave elastography in patients wit non-alcoholic steatohepatitis
Scientific Title:Acronym Elastography and non-alcoholic steatohepatitis
Region
Japan

Condition
Condition Non-alcoholic steatohepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Relation between findings about hepatic fibrosis by shear wave elastography and those by blood test and liver biopsy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relation between findings about hepatic fibrosis by shear wave elastography and those by blood test and liver biopsy.
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Pathological proven NASH patients
Key exclusion criteria Patients in which agreement to participate in the study was not obtained
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Noriaki
Middle name
Last name Manabe
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code 734-8551
Address 577 Matsushima, Kurashiki, Japan
TEL 086-462-1111
Email n_manabe@hkg.odn.ne.jp

Public contact
Name of contact person
1st name Noriaki
Middle name
Last name Manabe
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code 734-8551
Address 577 Matsushima, Kurashiki, Japan
TEL 086-462-1111
Homepage URL
Email n_manabe@hkg.odn.ne.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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 Kawasaki Medical School
Address 577 Matsushima, Kurashiki, Okayama
Tel 086-462-1111
Email kmsrec@med.kawasaki-m.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 川崎医科大学(岡山県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 93
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 Completed
Date of protocol fixation
2017 Year 09 Month 10 Day
Date of IRB
2010 Year 10 Month 16 Day
Anticipated trial start date
2017 Year 10 Month 16 Day
Last follow-up date
2018 Year 10 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Relationship between findings of liver fibrosis evaluated by the shear wave elastography and the those evaluated by blood test and those evaluated by liver biopsy.

Management information
Registered date
2017 Year 09 Month 17 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033253

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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