UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	MRI-based assessment of the risk factor for hepatocellular carcinoma of chronic hepatitis type C after anti-viral therapy
Title of the study (Brief title)	MRI for stratifying the risk of HCC after SVR by DAA
Region	Japan

Condition
Condition	Type C hepatitis
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To stratify the risk of HCC development in patients who had had type C hepatitis and have obtained SVR by DAA treatment
Basic objectives2	Others
Basic objectives -Others	MRI is being used for the screening of HCC in patients with chronic liver disease. Gadoxetic acid-enhanced hepatobiliary phase (HBP) hypointense nodule without arterial phase hyper enhancement is considered to become hyper vascular HCC over time. In this study, we aimed to stratify the risk of HCC development in patients who had had type C hepatitis and have achieved SVR by DAA treatment using the MRI findings obtained after achieving SVR.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HCC development
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have achieved SVR within 1 year or who is scheduled to receive DAA treatment
Key exclusion criteria	Patients who have not achieved SVR by DAA Patients who cannot undergo MRI within 1 year after SVR. Patients of <18 years old
Target sample size	1000

Research contact person
Name of lead principal investigator	Utaroh Motosugi
Organization	University of Yamanashi
Division name	Radiology
Address	1110 Shimokato, Chuo-Shi, Yamanashi
TEL	055-273-1111
Email	umotosugi@yamanashi.ac.jp

Public contact
Name of contact person	Utaroh Motosugi
Organization	University of Yamanashi
Division name	Radiology
Address	1110 Shimokato, Chuo-Shi, Yamanashi
TEL	055-273-1111
Homepage URL
Email	umotosugi@yamanashi.ac.jp

Sponsor
Institute	Department of Radiology, University of Yamanashi
Institute
Department

Funding Source
Organization	Bayer Healthcare
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2018 Year 09 Month 14 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 03 Day
Anticipated trial start date	2017 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	NA

Management information
Registered date	2018 Year 09 Month 14 Day
Last modified on	2018 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038915