UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003462
Receipt number R000004180
Scientific Title Signal transduction of heat shock protein in hepatitis and hepatocellular carcinoma
Date of disclosure of the study information 2010/04/08
Last modified on 2023/04/17 10:03:58

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Basic information

Public title

Signal transduction of heat shock protein in hepatitis and hepatocellular carcinoma

Acronym

Signal transduction of HSP in hepatitis and HCC

Scientific Title

Signal transduction of heat shock protein in hepatitis and hepatocellular carcinoma

Scientific Title:Acronym

Signal transduction of HSP in hepatitis and HCC

Region

Japan


Condition

Condition

hepatitis and hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This project aims to elucidate the roles of HSP in hepatitis and in hepatocellular carcinoma development.

Basic objectives2

Others

Basic objectives -Others

The expression and modification of the heat shock proteins and the proteins of related signal transduction in hepatitis and hepatocellular carcinoma are examined.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

HSPs and the related proteins expression in the liver tissues of chronic liver disease or HCC patients .

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

The patients wih chronic hepatitis or hepatocellular carcinoma

Key exclusion criteria

None

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Rie
Middle name
Last name Matsushima-Nishiwaki

Organization

Gifu University Graduate School of Medicine

Division name

Department of Pharmacology

Zip code

5001194

Address

Yanagito 1-1, Gifu, Gifu, Japan 501-1194

TEL

058-230-6214

Email

nishiwaki.rie.r7@f.gifu-u.ac.jp


Public contact

Name of contact person

1st name Rie
Middle name
Last name Nishiwaki-Matsushima

Organization

Gifu University Graduate School of Medicine

Division name

Department of Pharmacology

Zip code

5001194

Address

1-1 Yanagito, Gifu

TEL

058-230-6217

Homepage URL


Email

nishiwaki.rie.r7@f.gifu-u.ac.jp


Sponsor or person

Institute

Department of Pharmacology, Gifu University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Grants in Aid for Scientific Research from the Ministry of Education, Science, Sports and Culture of 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

Medical research ethics committee of Gifu University Graduate School of Medicine

Address

1-1 Yanagido, Gifu, Gifu, Japan

Tel

058-230-6000

Email

gjme00004@jim.gifu-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

2010 Year 04 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

2010 Year 02 Month 15 Day

Date of IRB

2010 Year 03 Month 02 Day

Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date

2029 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The tissues are obtained by surgical resection or percutaneous liver biopsy from the patients with hepatitis or hepatocellular carcinoma at the Department of Surgery, Ogaki Municipal Hospital. The resected tissues were snapfrozen in liquid nitrogen and then stored at -80 degree until used for the analysis.


Management information

Registered date

2010 Year 04 Month 08 Day

Last modified on

2023 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004180


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name