UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040277 |
|---|---|
| Receipt number | 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 | 2024/05/07 18:14:23 |
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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
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
nakamura-ma@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Nobelpharma Co., Ltd.
ASKA Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
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
2237
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
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044658
