Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients

• Conditions: Cardiotoxicity; Breast Cancer; Heart Failure

• Registration Number: NCT05298072
• Lead Sponsor: University Hospital, Essen

Brief Summary

This study aims to identify possible set of inflammatory biomarkers before, during and after anthracycline-based chemotherapy in breast cancer patients to identify (sub)clinical chemotherapy-related cardiac dysfunctionCRCD to identify patients who would benefit from additional cardioprotective therapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Study First Posted: 2022-03-28
• Last Update Posted: 2022-03-28
• Study Start: 2022-04
• Primary Completion: 2023-04
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• initial diagnosis of breast cancer
• planned Anthracycline-based therapy
• first-line chemotherapy
• first visit before initiation of chemotherapy

Exclusion Criteria

• previous chemotherapy
• medical history of cardiac disease
• inflammation-modulating medication
• medication with RAS inhibitors
• pregnancy
• autoimmune disease
• drug addictions
• unwilling or unable to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiotoxicity during observational period	continuous evaluation during observational period of 12 months	Defined according to IC-OS 2021 Consensus Criteria