Clinical Trial: A single-center prospective observational study on cardiovascular complications associated with anthracycline-based anticancer agents, focusing on doxorubicin (Japan)

Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058031) titled 'A single-center prospective observational study on cardiovascular complications associated with anthracycline-based anticancer agents, focusing on doxorubicin' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - Yamaguchi University

Condition: Condition - doxorubicin cardiomyopathy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to clarify the incidence of cardiomyopathy in patients administered doxorubicin. Basic objectives2 - Others

Eligibility: Age-lower limit - 16 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Inclusion Criteria (All of the following must be met):

1)Individuals aged 16 years or older at the time of obtaining informed consent

2)No restrictions based on sex

3)Patients scheduled to receive doxorubicin-based chemotherapy for malignant lymphoma in the Third Department of Internal Medicine at Yamaguchi University Hospital

4)Patients who have undergone, or are scheduled to undergo, echocardiography within six months prior to the initial administration of doxorubicin

5)Patients (or their legally authorized representatives) who have received sufficient explanation regarding participation in this study and have provided written informed consent based on adequate understanding and voluntary agreement Key exclusion criteria - 1)Patients with a history of prior treatment with anthracycline-based anticancer agents

2)Patients who, prior to the initial administration of doxorubicin, have a left ventricular ejection fraction (LVEF) of less than 50%, or exhibit symptoms suggestive of heart failure according to the Framingham criteria

3)Patients deemed unsuitable for participation in this study by the principal investigator or co-investigators for any other reason Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 04 Month 12 Day Anticipated trial start date - 2025 Year 06 Month 02 Day Last follow-up date - 2028 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065963

Disclaimer: Curated by HT Syndication.