UMIN-CTR Clinical Trial

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 Kazuhiko Middle name Last name Koike
Organization	Graduate School of Medicine, the University ofTokyo
Division name	Department of Gastroenterology
Zip code	113-8655
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 Tateishi Middle name Last name Ryosuke
Organization	Graduate School of Medicine, the University ofTokyo
Division name	Department of Gastroenterology
Zip code	113-8655
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	Research ethics committee of the university of Tokyo
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
Tel	+81-3-5841-0818
Email	ethics@m.u-tokyo.ac.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	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	Main results already published
Date of protocol fixation	2015 Year 12 Month 01 Day
Date of IRB	2015 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2025 Year 12 Month 01 Day
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	2022 Year 09 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026145