UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Features in Japanese Patients with Chronic Liver Diseases: A multicenter prospective long observational study
Acronym	C-CUBE study
Scientific Title	Clinical Features in Japanese Patients with Chronic Liver Diseases: A multicenter prospective long observational study
Scientific Title:Acronym	C-CUBE study
Region	Japan

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

Objectives
Narrative objectives1	To clarify the prognosis and frequency of complication among patients with chronic liver disease.
Basic objectives2	Others
Basic objectives -Others	To clarify the prognosis and frequency of complication among patients with chronic liver disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prognosis
Key secondary outcomes	Frequency of complication

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects must meet all of the following criteria to be included in this study. 1) a) Abnormal alanine aminotransferase (ALT) levels for at least 6 months before screening. Or b) Diagnosed as chronic hepatitis B virus infection, chronic hepatitis C virus infection, fatty liver disease, alcoholic liver injury, primary biliary cholangitis, autoimmune hepatitis, and other chronic liver diseases Or c) Diagnosed with cirrhosis Or d) Diagnosed as primary liver cancer 2) Male or female, at least 20 years of age at time of registration. 3) Subjects must understand all other protocol requirements and voluntarily sign and date an informed consent form prior to the initiation of any screening or study-specific procedures.
Key exclusion criteria	1) Recent history of drug or health, psychological, social problems that could preclude adherence to the protocol. 2) Any condition that could impair safety of subjects or could preclude adherence to the protocol in the opinion of the investigator.
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Naoya Middle name Last name Kato
Organization	Chiba University, Graduate school of medicine
Division name	Department of Gastroenterology
Zip code	260-8677
Address	1-8-1 Inohana, Chiba
TEL	043-226-2083
Email	kato.naoya@chiba-u.jp

Public contact
Name of contact person	1st name Masato Middle name Last name Nakamura
Organization	Chiba University, Graduate school of medicine
Division name	Department of Gastroenterology
Zip code	260-8677
Address	1-8-1 Inohana, Chiba
TEL	043-226-2083
Homepage URL
Email	nakamura-ma@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research ethics committee of the graduate school of medicine, Chiba university
Address	1-8-1 Inohana, Chiba
Tel	043-222-7171
Email	inohana-rinri@chiba-u.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	2020 Year 05 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	Open public recruiting
Date of protocol fixation	2019 Year 07 Month 19 Day
Date of IRB	2019 Year 09 Month 30 Day
Anticipated trial start date	2020 Year 02 Month 18 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Incidence rate of liver cancer or recurrence Mortality rate, cause of death Incidence rate of liver failure or cirrhosis Treatment history for liver disease Treatment status for chronic liver disease and liver cancer Rate of complication and treatment history Quality of life (QOL) score

Management information
Registered date	2020 Year 04 Month 30 Day
Last modified on	2020 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044658

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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