UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investiaton of comprehenve genetic mutation in patients with HCC and hepatitis.
Title of the study (Brief title)	The investiaton of comprehenve genetic mutation in patients with HCC and hepatitis.
Region	Japan

Condition
Condition	HCC/hepatitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To clatify the genetic mutation of the patients with HCC and hepatitis.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The genetic mutation of Tumor, Non tumor, buffy coat, plasma in patients with HCC and hepatitis.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Gene
Interventions/Control_1	We collect DNA from tumor, non-tumor, buffy coat, plasma.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	patients who conntract HCC or hepatitis
Key exclusion criteria	women who are pregnant
Target sample size	50

Research contact person
Name of lead principal investigator	Tatsuro Kanda
Organization	Chiba university
Division name	Department of gastroenterology
Address	1 8 1 Inohana Cyuo ward Chiba city
TEL	043-222-7171
Email	kandat-cib@umin.ac.jp

Public contact
Name of contact person	Tatsuro Kanda
Organization	Chiba university
Division name	gastroenterology and neohrology
Address	1 8 1 Inohana Cyuo ward Chiba city
TEL	043-222-7171
Homepage URL
Email	kandat-cib@umin.ac.jp

Sponsor
Institute	Chiba university
Institute
Department

Funding Source
Organization	Chiba university
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	2016 Year 10 Month 27 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 20 Day
Anticipated trial start date	2016 Year 04 Month 20 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

Management information
Registered date	2016 Year 10 Month 27 Day
Last modified on	2016 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028300