UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032493
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hrkawamoto@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.