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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016431
Receipt No. R000019080
Scientific Title Analysis of gene polymorphism in hepatocellular carcinoma patients treated with sorafenib therapy
Date of disclosure of the study information 2015/02/06
Last modified on 2015/02/03

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Basic information
Public title Analysis of gene polymorphism in hepatocellular carcinoma patients treated with sorafenib therapy
Acronym AGHCs
Scientific Title Analysis of gene polymorphism in hepatocellular carcinoma patients treated with sorafenib therapy
Scientific Title:Acronym AGHCs
Region
Japan

Condition
Condition Heoatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We investigated the relationship with side effects and prognosis according to gene polymorphism in hepatocellular carcinoma patients treated with sorafenib.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between side effects and gene polymorphism
Key secondary outcomes Relationship between prognosis and gene polymorphism

Base
Study type

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 sorafenib therapy
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. Clinical diagnosed hepatocellular carcinoma patients treated with sorafenib therapy, discontinued sorafenib therapy, or intended to treat with sorafenib therapy
2. Extrahepatic metastasis is no object.
3. Child-Pugh class A-B(7)
4. Good reserved function of main organs (bone marrow, kidney, and heart)
(1) WBC >/= 2000/mm3
(2) Plt >/= 5x104/mm3
(3) Hb >/= 8.0g/dL
(4) creatinine < 2mg/dL
(5) Heart function except exclusion criteria
5. Informed consentwas obtained.
Key exclusion criteria 1. Following serous comlicating diseases, except for chronic hepatitis and liver cirrhosis:
a) Renal failure with blood or peritoneal dialysis
b) Heart failure >/= NYHA class III, serious ischemic herat disease, and serious arhythmia
c) uncontrolled hypertension
d) brain tumors
2. Past or present history of malignant tumors except for HCC
3. Past history of allergy in iodine or contrast agent
4. Inadequate patient judged by a doctor
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Yamasaki
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Oncology and Laboratory Medicine
Zip code
Address 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2336
Email t.yama@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Issei Saeki
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2241
Homepage URL
Email issaeki@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Hospital
Institute
Department

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
Email

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
2015 Year 02 Month 06 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
2014 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 03 Day
Last modified on
2015 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019080

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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