UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008791 |
|---|---|
| Receipt number | R000010275 |
| Scientific Title | The usefulness of VTTQ (Virtual Tissue Touch Quantification) in patients with chronic liver disease |
| Date of disclosure of the study information | 2012/08/29 |
| Last modified on | 2019/08/02 15:14:18 |
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Basic information
Public title
The usefulness of VTTQ (Virtual Tissue Touch Quantification) in patients with chronic liver disease
Acronym
The estimation of liver fibrosis by VTTQ (Virtual Tissue Touch Quantification) in patients with chronic liver disease
Scientific Title
The usefulness of VTTQ (Virtual Tissue Touch Quantification) in patients with chronic liver disease
Scientific Title:Acronym
The estimation of liver fibrosis by VTTQ (Virtual Tissue Touch Quantification) in patients with chronic liver disease
Region
| Japan |
Condition
Condition
chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The usefulness of VTTQ (Virtual Tissue Touch Quantification) in patients with chronic liver disease as predictive factors for progression of liver disease and prediction and evaluation for treatment efficacy
Basic objectives2
Others
Basic objectives -Others
The usefulness of VTTQ (Virtual Tissue Touch Quantification) as the non-invasive method for evaluation of liver fibrosis in patients with chronic liver disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between progression of chronic liver disease and VTTQ
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic liver disease
Key exclusion criteria
Patients whom investigator disqualified
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryotaro |
| Middle name | |
| Last name | Sakamori |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
Homepage URL
sakamori@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 29 | 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
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The association between progression of chronic liver disease and VTTQ (Virtual Tissue Touch Quantification), and the predictive value of VTTQ for treatment efficacy of chronic liver disease
Management information
Registered date
| 2012 | Year | 08 | Month | 28 | Day |
Last modified on
| 2019 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010275
