UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006728 |
|---|---|
| Receipt number | R000007951 |
| Scientific Title | Surveillance study following the completion of "Peretinoin Phase2/3 study" |
| Date of disclosure of the study information | 2011/11/15 |
| Last modified on | 2014/01/10 16:06:58 |
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Basic information
Public title
Surveillance study following the completion of "Peretinoin Phase2/3 study"
Acronym
Cohort study with Peretinoin for HCC(Curative therapy)
Scientific Title
Surveillance study following the completion of "Peretinoin Phase2/3 study"
Scientific Title:Acronym
Cohort study with Peretinoin for HCC(Curative therapy)
Region
| Japan |
Condition
Condition
hepatocellular carcinoma with HCV-RNA positive
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of NIK-333(PERETINOIN) on the suppression of recurrence after curative therapy for HCC(sHCV-RNA positive)
Basic objectives2
Others
Basic objectives -Others
Over all saurvival
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall Survival
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who entered in NIK-333 PhaseII/III trial.
(Ref.JAPIC Clinical Trials Information: JapicCTI-060250)
Key exclusion criteria
"HBs" positive patient
Target sample size
392
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiwamu Okita M.D. |
Organization
Social insurance Alliance Shimonoseki KohseiHospital
Division name
President
Zip code
Address
Kamisinchichiyou 3-3-8,
TEL
083-231-5811
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Ohnishi |
Organization
Social insurance Alliance Shimonoseki Kohsei Hospital
Division name
Clinical Study Support Center
Zip code
Address
Kamisinchichiyou 3-3-8,
TEL
083-231-5811
Homepage URL
koseih_4@koseihp.jp
Sponsor or person
Institute
Social insurance Alliance Shimonoseki Kohsei Hospital
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 15 | 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
| 2011 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
Retrospective cohort study following the phase 2/3 study
Management information
Registered date
| 2011 | Year | 11 | Month | 15 | Day |
Last modified on
| 2014 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007951
