UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029177 |
|---|---|
| Receipt number | 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 14:05:56 |
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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
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
n_manabe@hkg.odn.ne.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033253
