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

JRCT ID: jRCT1030230492

Registered date:06/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: all cancer patients
• Date of first enrollment: 11/04/2023
• Target sample size: 300
• Study type: Observational

Outcome(s)

• Primary Outcome: 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

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include 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)

• Exclude criteria: none

Related Information

• Primary Sponsor: Shoji Masaaki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development