UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The role of BAFF, APRIL and the clinical significance of apoptotic factors in hepatocellular carcinoma
Title of the study (Brief title)	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	Yoichi Hiasa
Organization	Ehime University Graduate School of Medicine
Division name	Gastroenterology and Metabology
Address	Shitsukawa, Toon, Ehime 791-0295, JAPAN
TEL	089-960-5308
Email	3naika@m.ehime-u.ac.jp

Public contact
Name of contact person	Yoshinori Ohno
Organization	Ehime University Graduate School of Medicine
Division name	Gastroenterology and Metabology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 12 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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