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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040277
Receipt No. R000044658
Scientific Title Clinical Features in Japanese Patients with Chronic Liver Diseases: A multicenter prospective long observational study
Date of disclosure of the study information 2020/05/01
Last modified on 2020/04/30

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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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