UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study to investigate clinical factors predicting hepatocarcinogenesis after the eradication of hepatitis C virus.
Title of the study (Brief title)	A study to investigate clinical factors predicting hepatocarcinogenesis after HCV eradication.
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore factors predicting hepatocarcinogenesis after eradication of hepatitis C virus.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical factors associated with hepatocarcinogenesis after HCV eradication.
Key secondary outcomes	Cancer-free survival time after HCV eradication

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 hepatitis or liver cirrhosis who have received interferon-free anti-HCV therapy with oral antivirals for serotype 1 or 2 HCV infection.
Key exclusion criteria	1. Patients without any evaluation of the efficacy of anti-HCV therapy. 2. Patients whose clinical course after anti-HCV therapy cannot be tracked.
Target sample size	400

Research contact person
Name of lead principal investigator	Hiroyuki Marusawa
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-4319
Email	maru@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Haruhiko Takeda
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-4319
Homepage URL
Email	htakeda@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 28 Day
Anticipated trial start date	2017 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	Blood examination and abdominal ultrasound sonography or CT scan every 3 or 6 months are scheduled after anti-HCV therapy according to daily clinical practice.

Management information
Registered date	2017 Year 07 Month 31 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032502