UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008061 |
|---|---|
| Receipt number | R000009498 |
| Scientific Title | Domestic collaborative research of Genome-wide association study (GWAS) in predicting the therapeutic responce and adversed effect of new anticancer drugs for hepatocellular carcinoma. |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2018/12/04 13:44:03 |
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Basic information
Public title
Domestic collaborative research of Genome-wide association study (GWAS) in predicting the therapeutic responce and adversed effect of new anticancer drugs for hepatocellular carcinoma.
Acronym
New anticancer drugs for hepatocellular carcinoma and GWAS
Scientific Title
Domestic collaborative research of Genome-wide association study (GWAS) in predicting the therapeutic responce and adversed effect of new anticancer drugs for hepatocellular carcinoma.
Scientific Title:Acronym
New anticancer drugs for hepatocellular carcinoma and GWAS
Region
| Japan |
Condition
Condition
Hepatocellular carinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify genetic factor associated with therapeutic responce and adversed effect of new anticancer drug for hepatocellular carcinoma by use of genome-wide association study (GWAS)
Basic objectives2
Others
Basic objectives -Others
Relationship between genetic factor and therapeutic response / adversed effect to new anticancer drugs for the treatment of hepatocellular carcinoma
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between genetic factor and therapeutic response / adversed effect to new anticancer drugs for the treatment of hepatocellular carcinoma
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
New anticancer drugs for the treatment of hepatocellular carcinoma approved after April 2009
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
Patients with hepatocellular carcinoma who were treated by new anticancer drugs for the treatment of hepatocellular carcinoma approved after April 2009
Key exclusion criteria
Patients whom the physicians in charge judge their enrollment inappropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Graduate School of Medical Sciences, Kanazawa University
Division name
Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL
076-265-2233
s-kaneko@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Graduate School of Medical Sciences, Kanazawa University
Division name
Disease Control and Homeostasis
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL
076-265-2000
Homepage URL
s-kaneko@m-kanazawa.jp
Sponsor or person
Institute
Disease Control and Homeostasis, Graduate School of Medical Sciences, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences, Kanazawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
独立行政法人・国立国際医療肝炎センター（東京都），東京大学大学院医学系研究科・人類遺伝学教室（東京都），福井大学（福井県），愛媛大学（愛媛県），鳥取大学（鳥取県），千葉大学（千葉県），山口大学（山口県），大阪大学（大阪府），杏林大学（東京都），山形大学（山形県），昭和大学（東京都），兵庫医科大学（兵庫県），近畿大学（大阪府），岐阜大学（岐阜県），岡山大学（岡山県），久留米大学（福岡県），財団法人佐々木研究所附属杏雲堂病院（東京府），福井県済生会病院（福井県），埼玉医科大学（埼玉県），およびそれらの関連施設
Other administrative information
Date of disclosure of the study information
| 2012 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009498
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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