UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004599 |
|---|---|
| Receipt number | R000005334 |
| Scientific Title | Early evaluation of tumor response using contrast-enhanced ultrasonography for hepatocellular carcinoma treated with Solafenib |
| Date of disclosure of the study information | 2010/11/24 |
| Last modified on | 2014/05/23 11:03:39 |
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Basic information
Public title
Early evaluation of tumor response using contrast-enhanced ultrasonography for hepatocellular carcinoma treated with Solafenib
Acronym
Solafenib efficacy by E-US
Scientific Title
Early evaluation of tumor response using contrast-enhanced ultrasonography for hepatocellular carcinoma treated with Solafenib
Scientific Title:Acronym
Solafenib efficacy by E-US
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate early tumor response using contrast-enhanced ultrasonography, dynamic CT and MRI for hepatocellular carcinoma treated with Solafenib.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Tumor perfusion ( enhanced ultrasonography, enhanced CT, enhanced MRI)
Key secondary outcomes
Tumor markaer, histological change, liver function, cahnge in tumor size
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
unresectable or incurable HCC
Key exclusion criteria
1. T-Bil >3.0g/dl, PT 50%>
2.woman before menopause
3. woman during pregnancy or breast-feeding, who has plan for pregnancy
4. patient who has massive fluid collection
5. patient whom the doctor think as inappropriate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Fukuda |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
fukuhiro@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Fukuda |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
fukuhiro@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center Gastroenterological Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
横浜市立大学附属市民総合医療センター （神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 24 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
liver function
Management information
Registered date
| 2010 | Year | 11 | Month | 22 | Day |
Last modified on
| 2014 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005334
