臨床研究等提出・公開システム

Scientific Title	A Radiogenomics biomarker for predicting mutation sutatus and gene expresioon in hepatocellular carcinoma
Public Title	N/A

Contact for Scientific Queries	Name	Iwamoto Hideki
	Affiliation	Kurume University School of Medicine
	Address	67 Asahi machi Kurume City Fukuoka
	Telephone	+81-942-31-7561
	E-mail	iwamoto_hideki@med.kurume-u.ac.jp
Contact for Public Queries	Name	Iwamoto Hideki
	Affiliation	Kurume University School of Medicine
	Address	67 Asahi machi Kurume City Fukuoka
	Telephone	+81-942-31-7561
	E-mail	iwamoto_hideki@med.kurume-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		June. 27, 2023
Actual date of first enrollment		May. 08, 2023
Target sample size		200
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Diagnosed as HCC, and undergone surgery without any systemic therapy from April 2019 to April 2023 in Kurume univesity 2. Availabirity of contrast-enhanced CT images within 12 weeks before surgery and tumor tissue storage in Kurume university 3.Acquired informed consent form about use of tumor tissue before surgery in Kurume university
	Exclusion Criteria	Not applicable participants determined by an investigator
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hepatocellular Carcinoma
Intervention(s)
Health Condition(s) Keyword		Radiogenomics Artificial Intelligence
Intervention(s) Keyword
Health Condition(s) Code		D006528
Intervention(s) Code
Primary Outcome(s)		Evaluation of machine learning model for predicting B-catenin mutation from image features
Secondary Outcome(s)		Evaluation of machine learning model for predicting p53 mutation from image features Evaluation of machine learning model for predicting TERT mutation from image features

Primary Sponsor	Kurume University School of Medicine

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Eisai Co.,Ltd.
Secondary Sponsor	Applicable

Name of Certified Review Board	Kurume University Hospital
Address	67 Asahi machi Kurume City Fukuoka , Fukuoka
Telephone	+81-942-31-7200
E-Mail	i_rinri@kurume-u.ac.jp
Approval Status	Approval
Date of approval	April. 24, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none