UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008652
Receipt number R000010168
Scientific Title Study to identify the new molecules for liver carcinogenesis from chronic liver deseases and for cancer progeresssion.
Date of disclosure of the study information 2012/08/08
Last modified on 2020/08/14 20:36:53

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Basic information

Public title

Study to identify the new molecules for liver carcinogenesis from chronic liver deseases and for cancer progeresssion.

Acronym

Study for liver carcinogenesis.

Scientific Title

Study to identify the new molecules for liver carcinogenesis from chronic liver deseases and for cancer progeresssion.

Scientific Title:Acronym

Study for liver carcinogenesis.

Region

Japan


Condition

Condition

Chronic liver diseases and hepatocellular carcinoma

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to find the molecules related with liver carcinogenesis from chronic liver deseases, cancer progression and treatment effect. Moreover, we try to establish new treatment using new molecules we find.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection of new molecules, which overexpressed in hepatocellular carcinoma compared to non-tumor tissue.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients of hepatocellular carcinoma we can take informed concent to use the liver specimens obtained in surgical treatment or tumor biopsy for diagnosis, regardless of sex or age.

Key exclusion criteria

1. The patients who have poorly controlled cardiovascular, hematologic or pulmonary disease
2. The patients with pregnancy
3. The patients with severe depression or other psychiatric disorders

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoichi
Middle name
Last name Hiasa

Organization

Ehime University Graduate School of Medicine

Division name

Department of Gastroenterology and Metabology

Zip code

791-0295

Address

Shitsukawa, Toon, Ehime 791-0295, Japan

TEL

+81-89-960-5308

Email

hiasa@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name Yoichi
Middle name
Last name Hiasa

Organization

Ehime University Graduate School of Medicine

Division name

Department of Gastroenterology and Metabology

Zip code

791-0295

Address

Shitsukawa, Toon, Ehime 791-0295, Japan

TEL

+81-89-960-5308

Homepage URL


Email

hiasa@m.ehime-u.ac.jp


Sponsor or person

Institute

Ehime University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

a Grant-in-Aid for Scientific Research, Japan Society for the Promotion of Science, from the Ministry of Education, Culture, Sports, Science and Technology, Japan.

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

Institutional Review Board, Ehime University Hospital

Address

Shitsukawa, Toon, Ehime

Tel

089-960-5172

Email

rinri@m.ehime-u.ac.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

2012 Year 08 Month 08 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2007 Year 11 Month 01 Day

Date of IRB

2007 Year 11 Month 01 Day

Anticipated trial start date

2007 Year 11 Month 01 Day

Last follow-up date

2024 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We have identified some molecules, which over expressed in hepatocellular carcinoma. We are now analyzing their role for clinical importances.


Management information

Registered date

2012 Year 08 Month 08 Day

Last modified on

2020 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010168


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name