UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI in patients with chronic hepatitis C after the eradication of HCV
Title of the study (Brief title)	Changes in non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI in patients with chronic hepatitis C after the eradication of HCV
Region	Japan

Condition
Condition	Patients with chronic HCV infection who are planning to undergo antiviral therapy for HCV
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Serial observation of non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI including the evolution to hepatocellular carcinoma after the eradication of HCV in patients with chronic hepatitis C.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serial changes of non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI after the eradication of HCV in patients with chronic hepatitis C.
Key secondary outcomes	The incidence of the evolution of non-hypervascular hypointense nodules during hepatobiliary phase of Gd-EOB-DTPA enhanced MRI to hyper vascular tumors including hepatocellular carcinoma.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic HCV infection who are planning to undergo antiviral therapy for HCV.
Key exclusion criteria	Patients who have a history of hepatocellular carcinoma.
Target sample size	500

Research contact person
Name of lead principal investigator	Hidenori Toyoda
Organization	Ogaki Municipal Hospital
Division name	Gastroenterology
Address	4-86, Minaminokawa, Ogaki, Gifu
TEL	0584-81-3341(1563)
Email	tkumada@he.mirai.ne.jp

Public contact
Name of contact person	Hidenori Toyoda
Organization	Ogaki Municipal Hospital
Division name	Gastroenterology
Address	4-86, Minaminokawa, Ogaki, Gifu
TEL	0584-81-3341(1563)
Homepage URL
Email	tkumada@he.mirai.ne.jp

Sponsor
Institute	Department of Gastroenterology, Ogaki Municipal Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	大垣市民病院（岐阜県） （Ogaki Municipal Hospital）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 07 Month 09 Day
Anticipated trial start date	2014 Year 10 Month 01 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	Observation will be continued for maximum 10 years for patients with non-hypervascular hypo intense nodules by Gd-EOB-DTPA enhanced MRI who achieved the eradication of HCV.

Management information
Registered date	2015 Year 04 Month 02 Day
Last modified on	2017 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019740