UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007570 |
|---|---|
| Receipt number | R000008940 |
| Scientific Title | Multicenter cohort study of clinical feature, treatment modalities and prognosis of non-B non-C hepatocellular carcinoma |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2013/03/25 12:14:57 |
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Basic information
Public title
Multicenter cohort study of clinical feature, treatment modalities and prognosis of non-B non-C hepatocellular carcinoma
Acronym
non-B non-C hepatocellular carcinoma study
Scientific Title
Multicenter cohort study of clinical feature, treatment modalities and prognosis of non-B non-C hepatocellular carcinoma
Scientific Title:Acronym
non-B non-C hepatocellular carcinoma study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate clinical feature, treatment modalities and prognosis of non-B non-C hepatocellular carcinoma
Basic objectives2
Others
Basic objectives -Others
Etiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical feature, treatment modalities and prognosis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
negative HBs antigen and negative anti-HCV antibody
Key exclusion criteria
NA
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Koike |
Organization
The University of Tokyo Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
03-3815-5411
Homepage URL
tateishi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, The University of Tokyo Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Endpoint was set as survival.
Management information
Registered date
| 2012 | Year | 03 | Month | 25 | Day |
Last modified on
| 2013 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008940
