<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/NCT04407780</url>
  </required_header>
  <id_info>
    <org_study_id>00011928</org_study_id>
    <nct_id>NCT04407780</nct_id>
  </id_info>
  <brief_title>Cardio-Oncology Registry</brief_title>
  <acronym>CONFUCIUS</acronym>
  <official_title>Cardio-Oncologie: étude Pilote évaluant la faisabilité, Utilité Concrète, Interdisciplinaire d'Une Unité Spécialisée</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Georges Pompidou Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Georges Pompidou Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Cardio-oncology is an emerging field. Most of the data available have been issued from either&#xD;
      retrospective analysis, industry data or pharmacovigilance data. These data sources include a&#xD;
      number of bias.&#xD;
&#xD;
      CONFUCIUS is a single tertiary centre prospective registry including all patients who have&#xD;
      been referred for cardio-oncology assessemnt.&#xD;
&#xD;
      The objectives are to provide a comprehensive vue of cardoi-oncology, enable to detect early&#xD;
      signals of cardiotoxicity and enhance ancillary projetcts aiming at specific populations&#xD;
      (e.g., type of cancer) and/or drugs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Incidence of cardio-toxicty</measure>
    <time_frame>5 years</time_frame>
    <description>Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of cardiotoxicity</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation of cardio-toxicity overall, and in predefined subgroups; statistical associatoin with outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of cardioprotective strategies</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation between the use of cardiovascular drugs and the number of patients with cardiotoxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of underlying cardiovacsular profile</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation between underlying cardioascular profile and the number of patients with cardiotoxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of arrhythmias</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation between incident arrhythmias and cancer drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Precision medicine</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation between biomarkers with use of artificial intelligence and the number of patients with cardiotoxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oncology</measure>
    <time_frame>5 years</time_frame>
    <description>Adherence to oncology treatment plan as stated in the multidisciplinary team meeting in patients with cardio-oncology assessment compared to matched patients with no cardio-oncology assessment within our institution; outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular outcomes</measure>
    <time_frame>10 years</time_frame>
    <description>Assess cardiovascular outcomes (cardiovascular death, admission for heart failure, acute coronary syndrome, stroke).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any advserse event</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation between any adverse event, oncology treatment, and outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behaviour</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation of any behaviour treatment (exercice, rehabilitation, nutrition consultation) and the number of patents with cardiotoxocity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation between oncology treatments, cardiovascular therapies, behaviour therapies and the number of patients with metabolic disorders (diabetes or dyslipidemia).</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Cancer</condition>
  <condition>Cardiac Disease</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Arrhythmia</condition>
  <condition>Heart Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No interventions are planned</intervention_name>
    <description>Non applicable</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All prosepctive patients seen in the cardio-oncology clinic. Observational data will be&#xD;
        collected from the medical records. Outcomes measures according to scheduled follow-up&#xD;
        visits for their cardiovascular health.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  referred to cardio-oncology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mariana Mirabel, MD, PhD</last_name>
    <phone>+33156095636</phone>
    <email>mariana.mirabel@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Paris - Centre Université de Paris</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariana Mirabel, MD, PhD</last_name>
      <phone>+33156095636</phone>
      <email>mariana.mirabel@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.youtube.com/watch?v=_rCgdACAhUU</url>
    <description>Assistance Publique Hôpitaux de Paris' webinar</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>European Georges Pompidou Hospital</investigator_affiliation>
    <investigator_full_name>Mariana Mirabel</investigator_full_name>
    <investigator_title>MD, PhD, Assosiate Professor</investigator_title>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>heart</keyword>
  <keyword>cardiovascular</keyword>
  <keyword>cardio-oncology</keyword>
  <keyword>onco-cardiology</keyword>
  <keyword>phamacology</keyword>
  <keyword>precision medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04407780
org study id: 00011928
nct id: NCT04407780
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cardio-oncology is an emerging field. Most of the data available have been issued from either
      retrospective analysis, industry data or pharmacovigilance data. These data sources include a
      number of bias.

      CONFUCIUS is a single tertiary centre prospective registry including all patients who have
      been referred for cardio-oncology assessemnt.

      The objectives are to provide a comprehensive vue of cardoi-oncology, enable to detect early
      signals of cardiotoxicity and enhance ancillary projetcts aiming at specific populations
      (e.g., type of cancer) and/or drugs.
observational model: Cohort
time perspective: Prospective
measure: Incidence of cardio-toxicty
time frame: 5 years
description: Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic
measure: Analysis of cardiotoxicity
time frame: 5 years
description: Correlation of cardio-toxicity overall, and in predefined subgroups; statistical associatoin with outcomes.
measure: Analysis of cardioprotective strategies
time frame: 5 years
description: Correlation between the use of cardiovascular drugs and the number of patients with cardiotoxicity.
measure: Analysis of underlying cardiovacsular profile
time frame: 5 years
description: Correlation between underlying cardioascular profile and the number of patients with cardiotoxicity.
measure: Analysis of arrhythmias
time frame: 5 years
description: Correlation between incident arrhythmias and cancer drugs
measure: Precision medicine
time frame: 5 years
description: Correlation between biomarkers with use of artificial intelligence and the number of patients with cardiotoxicity.
measure: Oncology
time frame: 5 years
description: Adherence to oncology treatment plan as stated in the multidisciplinary team meeting in patients with cardio-oncology assessment compared to matched patients with no cardio-oncology assessment within our institution; outcomes.
measure: Cardiovascular outcomes
time frame: 10 years
description: Assess cardiovascular outcomes (cardiovascular death, admission for heart failure, acute coronary syndrome, stroke).
measure: Any advserse event
time frame: 5 years
description: Correlation between any adverse event, oncology treatment, and outcomes.
measure: Behaviour
time frame: 5 years
description: Correlation of any behaviour treatment (exercice, rehabilitation, nutrition consultation) and the number of patents with cardiotoxocity.
measure: Metabolic
time frame: 5 years
description: Correlation between oncology treatments, cardiovascular therapies, behaviour therapies and the number of patients with metabolic disorders (diabetes or dyslipidemia).
intervention type: Other
intervention name: No interventions are planned
description: Non applicable
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mariana Mirabel, MD, PhD
phone: +33156095636
email: mariana.mirabel@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
url: https://www.youtube.com/watch?v=_rCgdACAhUU
description: Assistance Publique Hôpitaux de Paris' webinar
responsible party type: Principal Investigator
investigator affiliation: European Georges Pompidou Hospital
investigator full name: Mariana Mirabel
investigator title: MD, PhD, Assosiate Professor
mesh term: Heart Diseases
mesh term: Metabolic Syndrome
sharing ipd: Undecided