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

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 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


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

Value
https://center6.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