New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

August 15, 2023 updated by: Cardiology Prague
Early detection and thus rapid therapy of cardiotoxicity related to chemotherapy are essential for restoring cardiovascular function. The complete recovery of the cardiovascular system decreases with time to identify the presence of cardiotoxic damage. The project aims to define new biomarkers for the early detection of cardiotoxicity in patients treated with chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The most effective approach to minimizing the consequences of cardiotoxicity of oncological treatment is its early identification, adjustment of oncological treatment (change of procedure, dose, drugs), and immediate initiation of cardiovascular therapy. However, the current standard for monitoring the cardiovascular system in cancer patients identifies cardiotoxicity only if functional impairment has already occurred, which precludes any chance of effective prevention. The aim of the project is to identify new biomarkers for the early detection of the cardiotoxic effect of chemotherapy in women with breast cancer.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women with breast cancer

Description

Inclusion Criteria:

  • Breast cancer
  • Chemotherapy with a known cardiotoxic side effect

Exclusion Criteria:

  • Known cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity
Diagnostic test: Blood sampling
Blood sample collection for mRNA determination
Diagnostic test: Echocardiography
Echocardiography for detection of ventricular dysfunction
Diagnostic test: 24-hours monitoring of ECG
Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity
Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity
Diagnostic test: Blood sampling
Blood sample collection for mRNA determination
Diagnostic test: Echocardiography
Echocardiography for detection of ventricular dysfunction
Diagnostic test: 24-hours monitoring of ECG
Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity
Diagnostic test: Cardio MRI
MRI for early detection of myocardial impairment caused by chemotherapy
Diagnostic test: 24 hours monitoring of BP
Diagnostic test for detection of hypertension as a consequence of cardiotoxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early detection of the cardiotoxic effect of chemotherapy using new biomarkers
Time Frame: one year follow-up.
Echocardiography and MRI detection of cardiotoxic effect of chemotherapy - dysfunction of left ventricle, arrythmias, hypertension
one year follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiology Prague

Collaborators

BioVendor LM
Oncology Center Medicon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version_Protocol_3_5_2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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