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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004599
Receipt No. 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

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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
Email 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
Email fukuhiro@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center Gastroenterological Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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