UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022089 |
|---|---|
| Receipt number | R000025470 |
| Scientific Title | Study of the usefulness of non invasive liver function evaluation technology by ultrasound elastography |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2016/04/27 01:24:53 |
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Basic information
Public title
Study of the usefulness of non invasive liver function evaluation technology by ultrasound elastography
Acronym
Study of the usefulness of non invasive liver function evaluation technology by ultrasound elastography
Scientific Title
Study of the usefulness of non invasive liver function evaluation technology by ultrasound elastography
Scientific Title:Acronym
Study of the usefulness of non invasive liver function evaluation technology by ultrasound elastography
Region
| Japan |
Condition
Condition
Not limited
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an algorithm for estimate fibrosis, inflammation and steatosis of the liver using Real-time Tissue Elastography (below RTE), Shear Wave Measurement (below SWM), and attenuation measurement, for liver disease patients undergoing liver biopsy or liver resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To develop an algorithm for estimate fibrosis, inflammation and steatosis of the liver
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
no gender restriction
20 years old more
Key exclusion criteria
Patients can not be measured by removing the ROI (region of interest Region of Interest) of elastography from tumor
Pregnant women or the patient during breast-feeding.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Kudo |
Organization
Kinki university faculty of medicine
Division name
Department of gastroenterology and gepatology
Zip code
Address
377-2, Ohnodai, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
yada@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Yada |
Organization
Kinki university faculty of medicine
Division name
Department of gastroenterology and hepatology
Zip code
Address
377-2, Ohnodai, Osaka-sayama, Osaka, Japan
TEL
073-366-0221
Homepage URL
yada@med.kindai.ac.jp
Sponsor or person
Institute
Kinki university faculty of medicine, Department of gastroenterology and hepatology
Institute
Department
Personal name
Funding Source
Organization
Ehime university
Musashino red cross hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2016 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025470
