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

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 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


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

Value
https://center6.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