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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023997
Receipt No. R000026145
Scientific Title A prospective and retrospective multicenter cohort study of hepatocellular carcionoma development in patients after hepatitis C virus eradication
Date of disclosure of the study information 2016/09/10
Last modified on 2016/09/08

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Basic information
Public title A prospective and retrospective multicenter cohort study of hepatocellular carcionoma development in patients after hepatitis C virus eradication
Acronym SMART-C V4
Scientific Title A prospective and retrospective multicenter cohort study of hepatocellular carcionoma development in patients after hepatitis C virus eradication
Scientific Title:Acronym SMART-C V4
Region
Japan

Condition
Condition Patients after eradication of hepatitis C virus
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the incidence and risk factor for hepatocellular carcinoma development after hepatitis C virus eradication
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of hepatocellular carcinoma after hepatitis C virus eradication
Key secondary outcomes Overall survival rate

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 1) Informed consent was obtained from each patient. (If written consent could not be obtained because patients were already dead or changed hospitals, information disclosure of this study on institution's website could be equated to obtained consent.
2) Chronic hepatitis C patients with or without cirrhosis who had achieved sustained virological response by antiviral therapies.
Key exclusion criteria 1) Patients who developed hepatocellular carcinoma before achieved sustained virological response.
2) Patients with hepatitis B virus or human immunodeficiency virus co-infection.
3) Patients who physicians considered unsuitable for this study.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko koike
Organization Graduate School of Medicine, the University ofTokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL +81-3-3815-5411
Email kkoike-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Tateishi
Organization Graduate School of Medicine, the University ofTokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL +81-3-3815-5411
Homepage URL http://park.itc.u-tokyo.ac.jp/livercancer/research/index
Email tateishi-tky@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, Graduate School of Medicine, the University ofTokyo
Institute
Department

Funding Source
Organization the Research Program on Hepatitis from
Japan Agency for Medical Research and Development, AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 09 Month 10 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
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is an observational study about the development of hepatocellular carcinoma after the eradication of hepatitis C virus.
Included patients are followed up by blood tests and ultrasonography every six months.


Management information
Registered date
2016 Year 09 Month 09 Day
Last modified on
2016 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026145

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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