CardiotoxicityNCT05992337
New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.
An observational study of Cardiotoxicity and Chemotherapy Effect, run by Cardiology Prague at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiotoxicity, Chemotherapy Effect, Chemotherapy Induced Systolic Dysfunction
- What is being tested?
- Blood sampling, Echocardiography and Cardio MRI
- How many people
- 200 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Sep 2021to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with breast cancer
Who may be able to join
- Breast cancer
- Chemotherapy with a known cardiotoxic side effect
Who cannot join
- Known cardiovascular disease
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
Cardiology Prague Ltd
Prague, 10100
Robert Petr, MD, +420 233 336 334, robert.petr81@gmail.com
- Recruiting
Oncology Center Medicon
Prague
Renata Kozevnikovova, MD., +420222501403, renata.kozevnikovova@onko-centrum.cz
About this study
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.
Read the 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.
- Being tested
- Blood sampling, Echocardiography, Cardio MRI, 24-hours monitoring of ECG, 24 hours monitoring of BP
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Blood sample collection for mRNA determination
EchocardiographyDiagnostic test
Echocardiography for detection of ventricular dysfunction
Cardio MRIDiagnostic test
MRI for early detection of myocardial impairment caused by chemotherapy
24-hours monitoring of ECGDiagnostic test
Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity
24 hours monitoring of BPDiagnostic test
Diagnostic test for detection of hypertension as a consequence of cardiotoxicity
| Study group | Role | What they receive |
|---|---|---|
| Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity | Not described Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Echocardiography; Diagnostic Test: 24-hours monitoring of ECG | |
| Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of the cardiotoxic effect of chemotherapy using new biomarkers
Echocardiography and MRI detection of cardiotoxic effect of chemotherapy - dysfunction of left ventricle, arrythmias, hypertension
Measured: one year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Sep 2021
- Primary completionNov 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiology Prague
- Sponsor type
- Research network
- Collaborators
- BioVendor LM, Oncology Center Medicon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992337
- Sponsor's protocol ID
- Version_Protocol_3_5_2021
- Status last verified
- Aug 2023
- First submitted
- 28 Sep 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.
- ClinicalTrials.gov ID
- NCT05992337
- Acronym / sponsor ID
- Version_Protocol_3_5_2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cardiology PragueResearch network
- Collaborators
- BioVendor LM, Oncology Center Medicon
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity | – | Diagnostic Test: Blood sampling, Diagnostic Test: Echocardiography, Diagnostic Test: 24-hours monitoring of ECG |
| Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity | – | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer
Key inclusion criteria (2 listed)
- Breast cancer
- Chemotherapy with a known cardiotoxic side effect
Key exclusion criteria (1 listed)
- Known cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sample collection for mRNA determination | Diagnostic test | Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity, Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity |
| EchocardiographyEchocardiography for detection of ventricular dysfunction | Diagnostic test | Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity, Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity |
| Cardio MRIMRI for early detection of myocardial impairment caused by chemotherapy | Diagnostic test | Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity |
| 24-hours monitoring of ECGDiagnostic test for detection of arrhythmias as a consequence of cardiotoxicity | Diagnostic test | Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity, Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity |
| 24 hours monitoring of BPDiagnostic test for detection of hypertension as a consequence of cardiotoxicity | Diagnostic test | Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Chemotherapy Effect, run by Cardiology Prague at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Petr, MD. (+420 233 336 334, robert.petr81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of the cardiotoxic effect of chemotherapy using new biomarkers (time frame: one year follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.