New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

Sponsor

Cardiology Prague (Other)

Overall Status

Recruiting

CT.gov ID

NCT05992337

Collaborator

BioVendor LM (Other), Oncology Center Medicon (Other)

200

Enrollment

Locations

Anticipated Duration (Months)

100

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiotoxicity Chemotherapy Effect Chemotherapy Induced Systolic Dysfunction	Diagnostic Test: Blood sampling Diagnostic Test: Echocardiography Diagnostic Test: Cardio MRI Diagnostic Test: 24-hours monitoring of ECG Diagnostic Test: 24 hours monitoring of BP

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	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: Cardio MRI MRI for early detection of myocardial impairment caused by chemotherapy Diagnostic Test: 24-hours monitoring of ECG Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity Diagnostic Test: 24 hours monitoring of BP Diagnostic test for detection of hypertension as a consequence of cardiotoxicity

Arm

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: Cardio MRI

MRI for early detection of myocardial impairment caused by chemotherapy

Diagnostic Test: 24-hours monitoring of ECG

Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity

Diagnostic Test: 24 hours monitoring of BP

Diagnostic test for detection of hypertension as a consequence of cardiotoxicity

Outcome Measures

Primary Outcome Measures

Early detection of the cardiotoxic effect of chemotherapy using new biomarkers [one year follow-up.]
Echocardiography and MRI detection of cardiotoxic effect of chemotherapy - dysfunction of left ventricle, arrythmias, hypertension

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Breast cancer
Chemotherapy with a known cardiotoxic side effect

Exclusion Criteria:

Known cardiovascular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology Prague Ltd	Prague		Czechia	10100
2	Oncology Center Medicon	Prague		Czechia

Sponsors and Collaborators

Cardiology Prague
BioVendor LM
Oncology Center Medicon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cardiology Prague

ClinicalTrials.gov Identifier:

NCT05992337

Other Study ID Numbers:

Version_Protocol_3_5_2021

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 16, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiotoxicity

Study Results

No Results Posted as of Aug 16, 2023