UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004431 |
|---|---|
| Receipt number | R000005287 |
| Scientific Title | Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease |
| Date of disclosure of the study information | 2010/10/21 |
| Last modified on | 2013/09/04 01:25:14 |
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Basic information
Public title
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
Acronym
FIBROELAST Study
Scientific Title
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
Scientific Title:Acronym
FIBROELAST Study
Region
| Japan |
Condition
Condition
Chronic Hepatitis B
Chronic Hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to validate the diagnostic value of Real-time Tissue Elastography by comparison with liver histology, serum marker or FibroScan in chronic hepatitis B or C patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography and histological diagnosis.
Key secondary outcomes
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography and serum maker.
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography and FibroScan.
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
* Male or female and at least 20 years of age
* Chronic hepatitis B or Chronic hepatitis C
* Subject is willing to fast for 8 hours prior to each study visit
Key exclusion criteria
* History of alcohol abuse (alcohol intake > 20g/day)
* Evidence or history of chronic hepatitis not caused by HBV or HCV
* During 6 months before registration to this trial has completed, nucleic acid analogue preparations or interferon therapy was performed.
* Pregnant or lactating patients
* Contraindications of liver biopsy or liver resection
Target sample size
500
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 Hepatology
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL
072-366-0221
m-kudo@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 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL
072-366-0221
Homepage URL
yada@med.kindai.ac.jp
Sponsor or person
Institute
Research Program of medical disease field of incurable diseases and cancer
«Field of hepatitis related research areas» provided dy the Ministry of Health Labor, and Welfare of Japan.
Institute
Department
Personal name
Funding Source
Organization
Research Program of medical disease field of incurable diseases and cancer
«Field of hepatitis related research areas» provided dy the Ministry of Health Labor, and Welfare of Japan.
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 10 | Month | 21 | 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
| 2010 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation test
Management information
Registered date
| 2010 | Year | 10 | Month | 21 | Day |
Last modified on
| 2013 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005287
