UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035136 |
|---|---|
| Receipt number | R000039643 |
| Scientific Title | The efficacy of molecular targeted therapy for unresectable hepatocellular carcinoma |
| Date of disclosure of the study information | 2018/12/04 |
| Last modified on | 2019/06/05 14:32:21 |
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Basic information
Public title
The efficacy of molecular targeted therapy for unresectable hepatocellular carcinoma
Acronym
The efficacy of molecular targeted therapy for liver cancer
Scientific Title
The efficacy of molecular targeted therapy for unresectable hepatocellular carcinoma
Scientific Title:Acronym
The efficacy of molecular targeted therapy for liver cancer
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of efficacy and side effect of molecular targeted therapy for hepatocellular carinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall suruvival
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases that the molecular targeting drug was induced according to the eligibility criteria of each medicine.
Key exclusion criteria
Cases which treatment was not consistent with a clinical guideline.
Cases hard to be followed up.
Cases the attending physician judges inappropriate as a subject of the current study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Takai |
Organization
Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075(751)4319
atsushit@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Takai |
Organization
Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
606-8507
Address
Kyoto
TEL
075(751)4319
Homepage URL
atsushit@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075(753)4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 04 | 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
| 2018 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not in particular
Management information
Registered date
| 2018 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039643
