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/NCT06007274</url>
    </required_header>
    <id_info>
      <org_study_id>CARDIO-04-2022</org_study_id>
      <nct_id>NCT06007274</nct_id>
    </id_info>
    <brief_title>Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors</brief_title>
    <acronym>TILT</acronym>
    <official_title>Troponin to Detect Major Cardiovasculaire Advserse Events on Immune: a Case Control Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut Mutualiste Montsouris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut Curie</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institut Mutualiste Montsouris</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>
        Recent guidelines suggest the use of troponin to detect immnune related cardiovascular&#xD;
        advserse events in patients treated by immune checkpoint inhibitors for cancer.&#xD;
  &#xD;
        However, there is no proof that patients on immune checkpoint inhibitors benefit from this&#xD;
        active surveillance strategy. The suspicion of cardiovascular events may lead to the&#xD;
        interruption of cancer therapies.&#xD;
  &#xD;
        The TILT study aims at assessing: (i) the efficiency of troponin measurments in asymptomatic&#xD;
        patients to prevent the further advent of major cardiovascular events; (ii) its safety in&#xD;
        terms of cancer therapy completion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Retrospective two-center study comparing two groups of patients on immune checkpoint&#xD;
        inhibitors:&#xD;
  &#xD;
          -  Group 1: active surveillance by serial troponin measures not prompted by cardiovascular&#xD;
             symptoms ;&#xD;
  &#xD;
          -  Group 2: no troponin measures.&#xD;
  &#xD;
        For any solid cancer or stage.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Major cardiovascular event</measure>
      <time_frame>5 years</time_frame>
      <description>Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Completion of cancer therapy as scheduled</measure>
      <time_frame>5 years</time_frame>
      <description>Cardiovascular contre indication to immune checkpoint inhibitors</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Cancer</condition>
    <condition>Immune Checkpoint Inhibitor</condition>
    <condition>Cardiovascular Biomarkers</condition>
    <arm_group>
      <arm_group_label>Active surveillance by means of troponin measurements</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>No active surveillance by means of troponin measurements</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>No intervention</description>
      <arm_group_label>Active surveillance by means of troponin measurements</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All adult solid cancer patients receiving immune checkpoint inhibitors&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All solid cancer patients treated by immune checkpoint inhibitors 2017-2022&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients enrolled in an invterventional study (e.g., pharma trial)&#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_official>
      <last_name>Mariana Mirabel, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institut Mutualiste Montsouris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Isabelle Sauret, Mme</last_name>
      <phone>+33156616705</phone>
      <email>isabelle.sauret@imm.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nathalie Bass, Mme</last_name>
      <phone>+33156616705</phone>
      <email>nathalie.bass@imm.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institut Mutualiste Montsouris</name>
        <address>
          <city>Paris</city>
          <zip>75014</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mariana MIRABEL, MD, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06007274
  org study id: CARDIO-04-2022
  nct id: NCT06007274
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Recent guidelines suggest the use of troponin to detect immnune related cardiovascular
        advserse events in patients treated by immune checkpoint inhibitors for cancer.
  
        However, there is no proof that patients on immune checkpoint inhibitors benefit from this
        active surveillance strategy. The suspicion of cardiovascular events may lead to the
        interruption of cancer therapies.
  
        The TILT study aims at assessing: (i) the efficiency of troponin measurments in asymptomatic
        patients to prevent the further advent of major cardiovascular events; (ii) its safety in
        terms of cancer therapy completion.
  Retrospective two-center study comparing two groups of patients on immune checkpoint
        inhibitors:
  
          -  Group 1: active surveillance by serial troponin measures not prompted by cardiovascular
             symptoms ;
  
          -  Group 2: no troponin measures.
  
        For any solid cancer or stage.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Major cardiovascular event
  time frame: 5 years
  description: Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death
  measure: Completion of cancer therapy as scheduled
  time frame: 5 years
  description: Cardiovascular contre indication to immune checkpoint inhibitors
  arm group label: Active surveillance by means of troponin measurements
  arm group label: No active surveillance by means of troponin measurements
  intervention type: Other
  intervention name: No intervention
  description: No intervention
  arm group label: Active surveillance by means of troponin measurements
  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
  role: Principal Investigator
  affiliation: Institut Mutualiste Montsouris
  last name: Isabelle Sauret, Mme
  phone: +33156616705
  email: isabelle.sauret@imm.fr
  last name: Nathalie Bass, Mme
  phone: +33156616705
  email: nathalie.bass@imm.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  sharing ipd: Undecided