UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Whole-genome sequencing and comprehensive variant analysis of combined hepatocellular-cholangiocarcinoma, cholangiolocellular carcinoma, CK19 positive HCC, and SOX9 positive HCC
Title of the study (Brief title)	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	Takamichi Ishii
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Surgery (Division of Hepato-Biliary-Pancreatic Surgery and Transplant Surgery)
Address	Shogoinkawaharacho 54, Sakyo-ku, Kyoto
TEL	075-751-3242
Email	taishii@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hiroshi Kawamoto
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Surgery (Division of Hepato-Biliary-Pancreatic Surgery and Transplant Surgery)
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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