UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016944 |
|---|---|
| Receipt number | R000019541 |
| Scientific Title | The role of BAFF, APRIL and the clinical significance of apoptotic factors in hepatocellular carcinoma |
| Date of disclosure of the study information | 2015/03/27 |
| Last modified on | 2017/01/05 13:09:56 |
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Basic information
Public title
The role of BAFF, APRIL and the clinical significance of apoptotic factors in hepatocellular carcinoma
Acronym
BAFF, APRIL,apoptotic factors in hepatocellular carcinoma
Scientific Title
The role of BAFF, APRIL and the clinical significance of apoptotic factors in hepatocellular carcinoma
Scientific Title:Acronym
BAFF, APRIL,apoptotic factors in hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the possibilities of BAFF, APRIL and apoptotic factors in hepatocellular carcinoma as a clinical marker and hepatocellular cancer therapeutic targets.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the possibilities as a clinical marker and hepatocellular cancer therapeutic targets.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) liver cancer, hepatitis, cases and healthy men and women perform a liver resection.
2) at the time of obtaining informed consent, is older than 20 years old.
3) subjects consent was obtained from the person in writing about the present study participation.
Key exclusion criteria
1) blood collection and liver tissue of harvesting is considered a health hazard.
2) age is less than 20 years old.
3) subjects for this study participated written consent was not obtained from the person.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Hiasa |
Organization
Ehime University Graduate School of Medicine
Division name
Gastroenterology and Metabology
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295, JAPAN
TEL
089-960-5308
3naika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Ohno |
Organization
Ehime University Graduate School of Medicine
Division name
Gastroenterology and Metabology
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295, JAPAN
TEL
089-960-5308
Homepage URL
ynori1975@gmail.com
Sponsor or person
Institute
Ehime University Graduate School of Medicine,Gastroenterology and Metabology
Institute
Department
Personal name
Funding Source
Organization
Ehime University Graduate School of Medicine,Gastroenterology and Metabology
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
YES
Study ID_1
1412015
Org. issuing International ID_1
Ehime University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛媛大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 27 | 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 | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During the registration
Management information
Registered date
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019541
