UMIN-CTR Clinical Trial

Basic information
Public title	Examination of Direct-Acting Antiviral treatment for hepatitis C on prognosis and recurrence of hepatocellular carcinoma
Acronym	Examination on prognosis and recurrence of DAA hepatocellular carcinoma
Scientific Title	Examination of impact on prognosis and recurrence Direct-Acting Antiviral for hepatitis C-related hepatocellular carcinoma after Treatment.
Scientific Title:Acronym	Examination of impact on prognosis and recurrence DAA for hepatitis C-related hepatocellular carcinoma after Treatment.
Region	Japan

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

Objectives
Narrative objectives1	We investigate the prognosis and recurrence effect of DAA administration for hepatitis C after hepatocellular carcinoma treatment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prognosis after treatment for hepatocellular carcinoma
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Pathological or abdominal ultrasonography (including contrast imaging with sonazoid), contrast-enhanced CT, EOB-MRI, diagnosed as a liver malignant tumor. 2) Patients who have been confirmed that there is no hepatocellular carcinoma by contrast-enhanced CT or EOB-MRI within 3 months after surgery after hepatectomy or RFA as the first treatment. 3) A patient with Child-Pugh classification A before hepatectomy or RFA. 4) DAA of non-administration is the first case of HCC. 5) In case of DAA is administered, wether of HCC may be the first or recurrence.
Key exclusion criteria	1) Patients who have been refused participation in this study. 2) Child-Pugh before liver resection or RFA is B or C. 3) Cases with distant metastasis before HCC treatment.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Ochi Middle name Last name Hironori
Organization	Matsuyama Red Cross Hospital
Division name	Center for Liver-Billiary-Pancreas
Zip code	7908524
Address	Bunkyo-cho 1, Matsuyama, Ehime.
TEL	0899241111
Email	hironori19810211@gmail.com

Public contact
Name of contact person	1st name Ochi Middle name Last name Hironori
Organization	Matsuyama Red Cross Hospital
Division name	Center for Liver-Billiary-Pancreas
Zip code	7908524
Address	Bunkyo-cho 1, Matsuyama, Ehime.
TEL	0899241111
Homepage URL
Email	hironori19810211@gmail.com

Sponsor
Institute	Matsuyama Red Cross Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Matsuyama Red Cross Hospital
Address	Center for Liver-Billiary-Pancreas
Tel	0899241111
Email	hironori19810211@gmail.com

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	2019 Year 09 Month 26 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	Completed
Date of protocol fixation	2019 Year 07 Month 01 Day
Date of IRB	2019 Year 07 Month 24 Day
Anticipated trial start date	2019 Year 09 Month 26 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	A retrospective study to confirm the effect

Management information
Registered date	2019 Year 09 Month 26 Day
Last modified on	2021 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043433