NCT05298072

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 17, 2022

Last Update Submit

March 17, 2022

Conditions

CardiotoxicityBreast CancerHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Cardiotoxicity during observational period

    Defined according to IC-OS 2021 Consensus Criteria

    continuous evaluation during observational period of 12 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients presenting to cardio-oncology unit complying with eligibility criteria

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CardiotoxicityBreast NeoplasmsHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and InjuriesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 28, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

December 1, 2023

Last Updated

March 28, 2022

Record last verified: 2022-03