UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030113 |
|---|---|
| Receipt number | 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 11:20:52 |
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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
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
yanoyo@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034382
