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 2023/05/08 12:23:32

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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 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

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

1743

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

2023 Year 05 Month 08 Day



Link to view the page

Value
https://center6.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