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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030113
Receipt No. R000034382
Scientific Title Analysis of hepatitis viruses in the liver cancer tissues
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/25

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Basic information
Public title Analysis of hepatitis viruses in the liver cancer tissues
Acronym Variation of hepatitis virused in the liver cancer
Scientific Title Analysis of hepatitis viruses in the liver cancer tissues
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshihiko Yano
Organization Kobe University Graduate School of Medicine
Division name Gastroenterology
Zip code
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
1st name
Middle name
Last name Yoshihiko Yano
Organization Kobe University Graduate School of Medicine
Division name Gastroenterology
Zip code
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)

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
2017 Year 12 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
2016 Year 10 Month 05 Day
Date of IRB
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

Other
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

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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