UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032493 |
|---|---|
| Receipt number | R000037056 |
| Scientific Title | Whole-genome sequencing and comprehensive variant analysis of combined hepatocellular-cholangiocarcinoma, cholangiolocellular carcinoma, CK19 positive HCC, and SOX9 positive HCC |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/05/07 14:14:14 |
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Basic information
Public title
Whole-genome sequencing and comprehensive variant analysis of combined hepatocellular-cholangiocarcinoma, cholangiolocellular carcinoma, CK19 positive HCC, and SOX9 positive HCC
Acronym
Whole-genome sequencing and comprehensive variant analysis of HCC with cancer stem cell features
Scientific Title
Whole-genome sequencing and comprehensive variant analysis of combined hepatocellular-cholangiocarcinoma, cholangiolocellular carcinoma, CK19 positive HCC, and SOX9 positive HCC
Scientific Title:Acronym
Whole-genome sequencing and comprehensive variant analysis of HCC with cancer stem cell features
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyse the genomic mutation in combined hepatocellular-cholangiocarcinoma, cholangiolocellular carcinoma, CK19 positive HCC, and SOX9 positive HCC
To confirm the relation between the genomic mutation and the clinicopathological features
To speculate the evolutionary changes in HCC carcinogenetic pathway
Basic objectives2
Others
Basic objectives -Others
Genetic analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relation between the genomic mutation and the clinicopathological features in combined hepatocellular-cholangiocarcinoma, cholangiolocellular carcinoma, CK19 positive HCC, and SOX9 positive HCC
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
Cases in which surgical resection for HCC were performed from Jan 2007 until Dec 2017 at Kyoto University Hospital and meet both of the conditions below.
(1) 20 years or older
(2) pathologically diagnosed with HCC
Key exclusion criteria
Cases in which written informed consent was not obtained
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamichi Ishii |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Surgery (Division of Hepato-Biliary-Pancreatic Surgery and Transplant Surgery)
Zip code
Address
Shogoinkawaharacho 54, Sakyo-ku, Kyoto
TEL
075-751-3242
taishii@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawamoto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Surgery (Division of Hepato-Biliary-Pancreatic Surgery and Transplant Surgery)
Zip code
Address
Shogoinkawaharacho 54, Sakyo-ku, Kyoto
TEL
075-751-3242
Homepage URL
hrkawamoto@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | 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
Observational study
Management information
Registered date
| 2018 | Year | 05 | Month | 07 | Day |
Last modified on
| 2018 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037056
