臨床研究等提出・公開システム

Date of registration	Dec. 06, 2023
Last modified on	Dec. 06, 2023
Trial ID	jRCT1030230492

Scientific Title	Observational study on the identification of subclinical biomarkers for anticancer drug-induced cardiac dysfunction
Public Title	Observational study on the identification of subclinical biomarkers for anticancer drug-induced cardiac dysfunction

Contact for Scientific Queries	Name	Shoji Masaaki
	Affiliation	National Cancer Center
	Address	5-1-1,Tsukiji,Chuo-ku,Tokyo
	Telephone	+81-3-3542-2511
	E-mail	shoji.sgh@me.com
Contact for Public Queries	Name	Shoji Masaaki
	Affiliation	National Cancer Center
	Address	5-1-1,Tsukiji,Chuo-ku,Tokyo
	Telephone	+81-3-3542-2511
	E-mail	mshoji@ncc.go.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Dec. 01, 2022
Actual date of first enrollment		April. 11, 2023
Target sample size		300
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Among patients diagnosed with cancer and receiving treatment, patients who meet all of the inclusion criteria below and do not fall under any of the exclusion criteria are targeted. Cancer patients who are scheduled to receive doxorubicin anticancer treatment Patients who have given written consent. Patients with preserved cardiac function (LVEF>53%) Patients with a predicted prognosis of 6 months or more at the time of initial examination Over 20 years old at the time of obtaining consent (regardless of gender)
	Exclusion Criteria	none
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		all cancer patients
Health Condition(s) Keyword		cancer
Primary Outcome(s)		Correlation between decreased cardiac function (LVEF<53% or 10% lower than LVEF before anticancer drug treatment) and changes in each biomarker in echocardiography
Secondary Outcome(s)		Relationship between heart failure signs (orthopnea, cyanosis, lower leg edema) and changes in biomarkers Relationship between diastolic dysfunction in cardiac ultrasound examination and changes in biomarkers Relationship between patient medical history and changes in biomarkers

Primary Sponsor	none

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Cancer Center Review Board
Address	5-1-1,Tsukiji, Chuo-ku, Tokyo
Telephone	+81-3-3542-2511
E-Mail	ncch-irb@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	Oct. 28, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none