UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027814 |
|---|---|
| Receipt number | R000031856 |
| Scientific Title | Analysis of HBV viral particle in liver tissues and systemic effects during chronic HBV infection |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2024/06/25 17:15:48 |
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Basic information
Public title
Analysis of HBV viral particle in liver tissues and systemic effects during chronic HBV infection
Acronym
Analysis of HBV infection and liver tissues
Scientific Title
Analysis of HBV viral particle in liver tissues and systemic effects during chronic HBV infection
Scientific Title:Acronym
Analysis of HBV infection and liver tissues
Region
| Japan |
Condition
Condition
Hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Analyze genomic change of liver tissues or liver cancer tissues after HBV infection
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observe genes related with cell to cell transduction and analyze relationship with HBV infection from surgically resected liver tissues that are diagnosed liver cancer
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
| 25 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
HBV related liver cancer patients who are given surgical resection
Key exclusion criteria
exclude primary biliary cirrhosis, autoimmune hepatitis and co-infected status of HBV and HCV
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Kawaguchi |
Organization
Kanazawa University
Division name
Department of Gastroenterology
Zip code
920-8641
Address
13-1 Takara-Machi, Ishikawa
TEL
076-265-2235
kawaguchi@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Kawaguchi |
Organization
Kanazawa University
Division name
Department of Gastroenterology
Zip code
920-8641
Address
13-1 Takara-Machi, Ishikawa
TEL
076-265-2235
Homepage URL
kawaguchi@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University
Address
13-1 Takara-Machi, Kanazawa, Ishikawa
Tel
076-265-2235
kawaguchi@m-kanazawa.jp
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 | 06 | Month | 26 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation analysis
Management information
Registered date
| 2017 | Year | 06 | Month | 19 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031856
