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NCT05298072 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05298072
Other study ID # 22-10590-BO
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2022
Est. completion date December 2023

Study information
Verified date March 2022
Source University Hospital, Essen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 180
Est. completion date December 2023
Est. primary completion date April 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Essen

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiotoxicity during observational period Defined according to IC-OS 2021 Consensus Criteria continuous evaluation during observational period of 12 months
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