UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Domestic collaborative research of Genome-wide association study (GWAS) in predicting the therapeutic responce and adversed effect of new anticancer drugs for hepatocellular carcinoma.
Title of the study (Brief title)	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	Shuichi Kaneko
Organization	Graduate School of Medical Sciences, Kanazawa University
Division name	Disease Control and Homeostasis
Address	13-1 Takara-machi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL	076-265-2233
Email	s-kaneko@m-kanazawa.jp

Public contact
Name of contact person	Shuichi Kaneko
Organization	Graduate School of Medical Sciences, Kanazawa University
Division name	Disease Control and Homeostasis
Address	13-1 Takara-machi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL	076-265-2000
Homepage URL
Email	s-kaneko@m-kanazawa.jp

Sponsor
Institute	Disease Control and Homeostasis, Graduate School of Medical Sciences, Kanazawa University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 11 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009498