xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05992337</url>
    </required_header>
    <id_info>
      <org_study_id>Version_Protocol_3_5_2021</org_study_id>
      <nct_id>NCT05992337</nct_id>
    </id_info>
    <brief_title>New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.</brief_title>
    <official_title>New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cardiology Prague</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>BioVendor LM</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Oncology Center Medicon</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cardiology Prague</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Early detection and thus rapid therapy of cardiotoxicity related to chemotherapy are&#xD;
        essential for restoring cardiovascular function. The complete recovery of the cardiovascular&#xD;
        system decreases with time to identify the presence of cardiotoxic damage. The project aims&#xD;
        to define new biomarkers for the early detection of cardiotoxicity in patients treated with&#xD;
        chemotherapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The most effective approach to minimizing the consequences of cardiotoxicity of oncological&#xD;
        treatment is its early identification, adjustment of oncological treatment (change of&#xD;
        procedure, dose, drugs), and immediate initiation of cardiovascular therapy. However, the&#xD;
        current standard for monitoring the cardiovascular system in cancer patients identifies&#xD;
        cardiotoxicity only if functional impairment has already occurred, which precludes any chance&#xD;
        of effective prevention. The aim of the project is to identify new biomarkers for the early&#xD;
        detection of the cardiotoxic effect of chemotherapy in women with breast cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2021</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Early detection of the cardiotoxic effect of chemotherapy using new biomarkers</measure>
      <time_frame>one year follow-up.</time_frame>
      <description>Echocardiography and MRI detection of cardiotoxic effect of chemotherapy - dysfunction of left ventricle, arrythmias, hypertension</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Cardiotoxicity</condition>
    <condition>Chemotherapy Effect</condition>
    <condition>Chemotherapy Induced Systolic Dysfunction</condition>
    <arm_group>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood sampling</intervention_name>
      <description>Blood sample collection for mRNA determination</description>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity</arm_group_label>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Echocardiography</intervention_name>
      <description>Echocardiography for detection of ventricular dysfunction</description>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity</arm_group_label>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Cardio MRI</intervention_name>
      <description>MRI for early detection of myocardial impairment caused by chemotherapy</description>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>24-hours monitoring of ECG</intervention_name>
      <description>Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity</description>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity</arm_group_label>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>24 hours monitoring of BP</intervention_name>
      <description>Diagnostic test for detection of hypertension as a consequence of cardiotoxicity</description>
      <arm_group_label>Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women with breast cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Breast cancer&#xD;
  &#xD;
            -  Chemotherapy with a known cardiotoxic side effect&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known cardiovascular disease&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Breast cancer chemotherapy population</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Robert Petr, MD.</last_name>
      <phone>+420 233 336 334</phone>
      <email>robert.petr81@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cardiology Prague Ltd</name>
        <address>
          <city>Prague</city>
          <zip>10100</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Robert Petr, MD</last_name>
        <phone>+420 233 336 334</phone>
        <email>robert.petr81@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Oncology Center Medicon</name>
        <address>
          <city>Prague</city>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Renata Kozevnikovova, MD.</last_name>
        <phone>+420222501403</phone>
        <email>renata.kozevnikovova@onko-centrum.cz</email>
      </contact>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 28, 2021</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiotoxicity</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05992337
  org study id: Version_Protocol_3_5_2021
  nct id: NCT05992337
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Case-Control
  time perspective: Prospective
  measure: Early detection of the cardiotoxic effect of chemotherapy using new biomarkers
  time frame: one year follow-up.
  description: Echocardiography and MRI detection of cardiotoxic effect of chemotherapy - dysfunction of left ventricle, arrythmias, hypertension
  arm group label: Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity
  arm group label: Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity
  intervention type: Diagnostic Test
  intervention name: Blood sampling
  description: Blood sample collection for mRNA determination
  arm group label: Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity
  arm group label: Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity
  intervention type: Diagnostic Test
  intervention name: Echocardiography
  description: Echocardiography for detection of ventricular dysfunction
  arm group label: Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity
  arm group label: Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity
  intervention type: Diagnostic Test
  intervention name: Cardio MRI
  description: MRI for early detection of myocardial impairment caused by chemotherapy
  arm group label: Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity
  intervention type: Diagnostic Test
  intervention name: 24-hours monitoring of ECG
  description: Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity
  arm group label: Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity
  arm group label: Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity
  intervention type: Diagnostic Test
  intervention name: 24 hours monitoring of BP
  description: Diagnostic test for detection of hypertension as a consequence of cardiotoxicity
  arm group label: Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Breast cancer chemotherapy population
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Robert Petr, MD.
  phone: +420 233 336 334
  email: robert.petr81@gmail.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Czechia
  responsible party type: Sponsor
  mesh term: Cardiotoxicity