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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029074
Receipt No. R000033255
Scientific Title The mortality of chronic liver diseases including viral hepatitis and non alcoholic liver disease in Kyoto north area
Date of disclosure of the study information 2017/12/01
Last modified on 2018/03/12

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Basic information
Public title The mortality of chronic liver diseases including viral hepatitis and non alcoholic liver disease in Kyoto north area
Acronym The mortality of chronic liver disease
Scientific Title The mortality of chronic liver diseases including viral hepatitis and non alcoholic liver disease in Kyoto north area
Scientific Title:Acronym The mortality of chronic liver disease
Region
Japan

Condition
Condition Chronic liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to find out the prevalence and the risk of HCC, liver failure, the event of cardiovascular events in the patients with chronic liver disease.
Basic objectives2 Others
Basic objectives -Others The aims is to assess the mortality of chronic liver diseases.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The prevalence of the liver disease related events; HCC, esophagus varices, liver failure. and the cardiovascular events during 10 years observation period.
Key secondary outcomes Overall survival, the direct cause of death, the rate of haepato-carcinogenesis, the rate of SVR and reccurance of HCV, the stage of liver fibrosis, the IHC of LOX-1, aSMA, TGFb in the liver tissues, the concentration of serum sLOX-1.

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 Chronic liver disease patients going to North Medical Center of Kyoto prefectural university of medicine.
Key exclusion criteria No exclusion criteria
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ishiba
Organization North medical center, Kyoto prefectural university of medicine
Division name Gastroenterology
Zip code
Address Yosagun Yosanocho Otokoyama 481, Kyoto, Japan
TEL 0772463371
Email chiroinu@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Ishiba
Organization North medical center, Kyoto prefectural university of medicine
Division name Gastroenterology
Zip code
Address Yosagun Yosanocho Otokoyama 481, Kyoto, Japan
TEL 0772463371
Homepage URL
Email chiroinu@koto.kpu-m.ac.jp

Sponsor
Institute North medical center Kyoto prefectural university of medicine
Institute
Department

Funding Source
Organization North medical center Kyoto prefectural university of medicine
Organization
Division
Category of Funding Organization Local Government
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 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
2017 Year 12 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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 under trial

Management information
Registered date
2017 Year 09 Month 10 Day
Last modified on
2018 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033255

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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