UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006761 |
|---|---|
| Receipt number | 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 09:09:26 |
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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
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
Sponsor or person
Institute
Kyoundo hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007996
