UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037041 |
|---|---|
| Receipt number | R000042205 |
| Scientific Title | Multicenter Collaborative Research on Molecularly Targeted Drug Therapy for Advanced Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2020/12/14 17:32:13 |
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Basic information
Public title
Multicenter Collaborative Research on Molecularly Targeted Drug Therapy for Advanced Hepatocellular Carcinoma
Acronym
Multicenter Collaborative Research on Molecularly Targeted Drug Therapy for Advanced Hepatocellular Carcinoma
Scientific Title
Multicenter Collaborative Research on Molecularly Targeted Drug Therapy for Advanced Hepatocellular Carcinoma
Scientific Title:Acronym
Multicenter Collaborative Research on Molecularly Targeted Drug Therapy for Advanced 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 study the actual use, therapeutic effects and side effects of molecularly targeted drugs at multiple centers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival,progression-free survival
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
TACE refractory patients with advanced liver cancer
Key exclusion criteria
Patients who are allergic to molecularly targeted drugs
Patients who were able to confirm their intention to refuse participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naotaka |
| Middle name | |
| Last name | Shimozato |
Organization
Nara Medical University
Division name
Third Department of Internal Medicine
Zip code
634-0813
Address
shijo-cho 840, kashihara city
TEL
0744223051
shimozato@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Naotaka |
| Middle name | |
| Last name | Shimozato |
Organization
Nara Medical University
Division name
Third Department of Internal Medicine
Zip code
634-0813
Address
shijo-cho 840, kashihara city
TEL
0744223051
Homepage URL
shimozato@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University Third Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University Third Department of Internal Medicine
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
Nara Medical University
Address
shijo-cho 840, kashihara city
Tel
0744223051
kenkyu@naramed-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
| 2019 | Year | 07 | Month | 01 | 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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special instruction
Management information
Registered date
| 2019 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042205
