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

Sponsor
University Hospital, Essen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05298072
Collaborator
(none)
180
Enrollment
20
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    180 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients
    Anticipated Study Start Date :
    Apr 1, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Cardiotoxicity during observational period [continuous evaluation during observational period of 12 months]

      Defined according to IC-OS 2021 Consensus Criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Essen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Essen
    ClinicalTrials.gov Identifier:
    NCT05298072
    Other Study ID Numbers:
    • 22-10590-BO
    First Posted:
    Mar 28, 2022
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Cardiotoxicity
    Inflammation

    Study Results

    No Results Posted as of Mar 28, 2022