New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

NCT ID: NCT05992337

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiotoxicity Chemotherapy Effect Chemotherapy Induced Systolic Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity

Blood sampling

Intervention Type DIAGNOSTIC_TEST

Blood sample collection for mRNA determination

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Echocardiography for detection of ventricular dysfunction

24-hours monitoring of ECG

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity

Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity

Blood sampling

Intervention Type DIAGNOSTIC_TEST

Blood sample collection for mRNA determination

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Echocardiography for detection of ventricular dysfunction

Cardio MRI

Intervention Type DIAGNOSTIC_TEST

MRI for early detection of myocardial impairment caused by chemotherapy

24-hours monitoring of ECG

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity

24 hours monitoring of BP

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for detection of hypertension as a consequence of cardiotoxicity

Interventions

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Blood sampling

Blood sample collection for mRNA determination

Intervention Type DIAGNOSTIC_TEST

Echocardiography

Echocardiography for detection of ventricular dysfunction

Intervention Type DIAGNOSTIC_TEST

Cardio MRI

MRI for early detection of myocardial impairment caused by chemotherapy

Intervention Type DIAGNOSTIC_TEST

24-hours monitoring of ECG

Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity

Intervention Type DIAGNOSTIC_TEST

24 hours monitoring of BP

Diagnostic test for detection of hypertension as a consequence of cardiotoxicity

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Breast cancer
* Chemotherapy with a known cardiotoxic side effect

Exclusion Criteria

* Known cardiovascular disease
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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BioVendor LM

UNKNOWN

Sponsor Role collaborator

Oncology Center Medicon

UNKNOWN

Sponsor Role collaborator

Cardiology Prague

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardiology Prague Ltd

Prague, , Czechia

Site Status RECRUITING

Oncology Center Medicon

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Robert Petr, MD.

Role: CONTACT

+420 233 336 334

Facility Contacts

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Robert Petr, MD

Role: primary

+420 233 336 334

Renata Kozevnikovova, MD.

Role: primary

+420222501403

Other Identifiers

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Version_Protocol_3_5_2021

Identifier Type: -

Identifier Source: org_study_id

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