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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016944
Receipt No. 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

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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
Email 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
Email ynori1975@gmail.com

Sponsor
Institute Ehime University Graduate School of Medicine,Gastroenterology and Metabology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019541

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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