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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006761
Receipt No. R000007996
Scientific Title Efficacy of interferon therapy for recurrence-free and overall survival after curative radiofrequency ablation for HCV-related hepatocellular carcinoma.
Date of disclosure of the study information 2011/11/24
Last modified on 2011/11/24

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Basic information
Public title Efficacy of interferon therapy for recurrence-free and overall survival after curative radiofrequency ablation for HCV-related hepatocellular carcinoma.
Acronym IFN Therapy after RFA for HCC
Scientific Title Efficacy of interferon therapy for recurrence-free and overall survival after curative radiofrequency ablation for HCV-related hepatocellular carcinoma.
Scientific Title:Acronym IFN Therapy after RFA for HCC
Region
Japan

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

Objectives
Narrative objectives1 Efficacy of interferon therapy for recurrence-free and overall survival after curative radiofrequency ablation for HCV-related hepatocellular carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Recurrence rate
Key secondary outcomes Overall survival
Liver Function
Virus eradication

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PEG-IFN alpha 2a and RBV
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 Patients without recurrence of HCC at least three months after curative radiofrequency ablation for naive HCC, first recurrence HCC and second recurrence HCC.
Key exclusion criteria 1)uncontrollable heart disease
2)extrahepatic metastasis of hepatocellular carcinoma
3)another active cancer
4)chronic renal failure
5)taking Shosai-Koto(Chinese medicine)
6)autoimmune and other viral hepatitis
7)depression and psychiatric disease
8)pregnancy and during lactation

Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinpei Sato
Organization Kyoundo hospital
Division name gastroenterology and hepatology
Zip code
Address 1-8 Surugadai Kanda Chiyoda-Ku, Tokyo, Japan
TEL 03-3292-2051
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinpei Sato
Organization Kyoundo hospital
Division name gastroenterology and hepatology
Zip code
Address 1-8 Surugadai Kanda Chiyoda-Ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kyoundo 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
Address
Tel
Email

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 NTT東日本関東病院(東京都)、関東中央病院(東京都)、JR東京総合病院(東京都)、杏雲堂病院(東京都)、都立駒込病院(東京都)、三井記念病院(東京都)、日本赤十字社医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 24 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 Enrolling by invitation
Date of protocol fixation
2011 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 22 Day
Last modified on
2011 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007996

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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