UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021461 |
|---|---|
| Receipt number | R000024746 |
| Scientific Title | A prospective cohort study of efficacy and safety by methods of the procedure of transcatheter arterial chemoembolization with hepatocellular carcinoma. |
| Date of disclosure of the study information | 2016/03/13 |
| Last modified on | 2016/03/13 16:54:51 |
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Basic information
Public title
A prospective cohort study of efficacy and safety by methods of the procedure of transcatheter arterial chemoembolization with hepatocellular carcinoma.
Acronym
A prospective cohort study of efficacy and safety by methods of the procedure of transcatheter arterial chemoembolization with hepatocellular carcinoma.
Scientific Title
A prospective cohort study of efficacy and safety by methods of the procedure of transcatheter arterial chemoembolization with hepatocellular carcinoma.
Scientific Title:Acronym
A prospective cohort study of efficacy and safety by methods of the procedure of transcatheter arterial chemoembolization with hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety by methods of the procedure of transcatheter arterial chemoembolization with hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antitumor effect of each nodule after 3 months of TACE
Key secondary outcomes
Response rate
Time to Progression
Overall Survival
Incidence rate of adverse events
severity of vascular damage
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
1) Presence of histologically confirmed or clinically diagnosed hepatocellular carcinoma
2) At least 1 target lesion measurable
3) 20 years or more
4) Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 2
5) Child-Pugh classification A or B
6) Life expectancy of at least 12 weeks
7) Written informed consent
Key exclusion criteria
1) Cre <= ULN x 1.5
2) Severe cardiac disease
3) Severe cerebrovascular disease
4) interstitial pneumoniae
5) Active infection(except HBV and HCV infection)
6) Dynamic CT or EOB-MRI cannot be performed
7) Pregnant or lactating woman
8) Any patients judged by the investigator to be unfit to participate in the study
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokosuka |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba
TEL
043-222-7171
yokosukao@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | WakamatsuToru |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba
TEL
043-222-7171
Homepage URL
t_wakamatsu_3333@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
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
| 2016 | Year | 03 | Month | 13 | 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
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare efficacy and safety between patients treated with Baloon-occluded TACE, drug eluting bead (DEB)-TACE (non baloon-occluded) and DEB-TACE (baloon-occluded).
Management information
Registered date
| 2016 | Year | 03 | Month | 13 | Day |
Last modified on
| 2016 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024746
