UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of hepatitis viruses in the liver cancer tissues
Title of the study (Brief title)	Variation of hepatitis virused in the 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	To examine the specific mutation/variation/region in HBV genome in relation to hepatocarcinogenesis, the difference of HBV quasispecies between HBs antigen positive HCC and occult HBV infected HCC will be analysed.
Basic objectives2	Others
Basic objectives -Others	Analysis of HBV mutation and quasispecies using next-generation sequencer
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To be clarify the specific mutation/region in relation to hepatocarcinogenesis in HBs antigen positive HCC and OBI-related HCC
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	Patients who HCC was surgically resected.
Key exclusion criteria	Paitents who rejected in this study.
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshihiko Yano
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Address	7-5-1 Chuo-ku, Kusunoki-cho, Kobe 650-0017
TEL	078-382-6305
Email	yanoyo@med.kobe-u.ac.jp

Public contact
Name of contact person	Yoshihiko Yano
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Address	7-5-1 Chuo-ku, Kusunoki-cho, Kobe 650-0017
TEL	078-382-6305
Homepage URL
Email	yanoyo@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 10 Month 05 Day
Anticipated trial start date	2016 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Blood examination, histological fibrosis, medical history will be included for analysis.

Management information
Registered date	2017 Year 11 Month 25 Day
Last modified on	2017 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034382