臨床研究等提出・公開システム

Date of registration	Aug. 17, 2020
Last modified on	Aug. 17, 2020
Trial ID	jRCT1020200017

Scientific Title	A pilot study of tumor volume monitoring in unresectable hepatocellular carcinoma using circulating tumor DNA
Public Title	Monitoring of tumor volume of hepatocellular carcinoma by circulating tumor DNA

Contact for Scientific Queries	Name	Suzuki Yuji
	Affiliation	Iwate Medical University
	Address	1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
	Telephone	+81-28-3694
	E-mail	yusuzuki@iwate-med.ac.jp
Contact for Public Queries	Name	Suzuki Yuji
	Affiliation	Iwate Medical University
	Address	1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
	Telephone	+81-19-651-5111
	E-mail	yusuzuki@iwate-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 15, 2020
Target sample size		5
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with BCLC stage B or C unresectable hepatocellular carcinoma who are not eligible for local therapy. Patients who are receiving a new molecularly targeted drug such as sorafenib or lenvatinib will be eligible for the study. Other patients participating in clinical trials of molecularly targeted drugs being conducted will also be eligible.
	Exclusion Criteria	Any of the following 1) to 4) 1) Patients who have been informed by themselves or their representatives that they will not participate in the research. 2) Patients who are deemed unsuitable for inclusion in the study by the attending physician. 3) Patients whose mutant genes were not identified in next-generation sequencing analysis of primary tissues. 4) Patients with no next of kin to obtain final consent for pathology at the time of death.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hepatocellular Carcinoma
Health Condition(s) Keyword		advanced-stage hepatocellular carcinoma, unresectable hepatocellular carcinoma
Health Condition(s) Code		D006528
Primary Outcome(s)		Objective response rate assessed by mRECIST on CT and MRI at 2 months after the start of treatment.
Secondary Outcome(s)		Progression free survival and overall survival as assessed by mRECIST on CT and MRI two months after the start of treatment.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Iwate Medical University
Address	2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
Telephone	+81-19-651-5111
E-Mail	kenkyu-rinri@j.iwate-med.ac.jp
Approval Status	Approval
Date of approval	Aug. 01, 2019

Countries of Recruitment（Except Japan）	none