UMIN-CTR Clinical Trial

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
Institute	Ehime University Graduate School of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010168