UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004273 |
|---|---|
| Receipt number | R000005125 |
| Scientific Title | Prospective cohort study of early predictive markers of outcome in hepatocellular carcinoma patients after transcatheter arterial chemoembolization (TACE) |
| Date of disclosure of the study information | 2010/09/30 |
| Last modified on | 2010/09/27 22:13:40 |
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Basic information
Public title
Prospective cohort study of early predictive markers of outcome in hepatocellular carcinoma patients after transcatheter arterial chemoembolization (TACE)
Acronym
Prospective cohort study of early predictive markers of outcome in HCC after TACE
Scientific Title
Prospective cohort study of early predictive markers of outcome in hepatocellular carcinoma patients after transcatheter arterial chemoembolization (TACE)
Scientific Title:Acronym
Prospective cohort study of early predictive markers of outcome in HCC after TACE
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the independent early-
predictive markers of outcome such as the deterioration of Child's score and the development of ascites after TACE
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The deterioration of Child's score and the development of ascites 3 months after to before TACE
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Indirect calorimetry in pre-TACE and 7 days after TACE
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
All patients who were not adapted to the exclusion criteria were treated with segmental TACE.
Key exclusion criteria
Those who had refractory ascites, overt hepatic encephalopathy, uncontrolled esophageal varices, severe jaundice, Child's grade C and portal vein trunk thrombosis were excluded from the study. In addition, those who used intravenous albumin regularly were also excluded.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Seo |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
masaya@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kobe University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 30 | 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
| 2008 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | 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
Management information
Registered date
| 2010 | Year | 09 | Month | 27 | Day |
Last modified on
| 2010 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005125
