UMIN-CTR Clinical Trial

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 Hiroshi Middle name Last name Ishiba
Organization	Kyoto prefectural university of medicine
Division name	Gastroenterology
Zip code	602-8566
Address	Kamigyoku kawaramatichitori hirokojiagaru kajiicho 465, Kyoto, Japan
TEL	0752515519
Email	chiroinu@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Ishiba
Organization	Kyoto prefectural university of medicine
Division name	Gastroenterology
Zip code	602-8566
Address	Kamigyoku kawaramatichitori hirokojiagaru kajiicho 465, Kyoto, Japan
TEL	0752515519
Homepage URL
Email	chiroinu@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto prefectural university of medicine
Institute
Department

Funding Source
Organization	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	Kyoto prefectural university of medicine IRB
Address	Kamigyoku kawaramatichitori hirokojiagaru kajiicho 465, Kyoto, Japan
Tel	0752515519
Email	rinri@koto.kpu-m.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	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	2017 Year 12 Month 18 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
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	2021 Year 03 Month 23 Day

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