<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/NCT03826043</url>
  </required_header>
  <id_info>
    <org_study_id>2018/23</org_study_id>
    <nct_id>NCT03826043</nct_id>
  </id_info>
  <brief_title>THrombo-Embolic Event in Onco-hematology</brief_title>
  <acronym>THEO</acronym>
  <official_title>&quot;Prospective Study Evaluating the Impact and Treatment of Thrombo-embolic Events in Patients With Cancer&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Antoine Lacassagne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Antoine Lacassagne</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>
      The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200&#xD;
      cancer patients, about 5 times higher than in the general population.&#xD;
&#xD;
      These events are of crucial importance, since nearly 10% of cancer patients died from&#xD;
      thromboembolic events (EVT), making them the second leading cause of death in this&#xD;
      population.&#xD;
&#xD;
      In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% -&#xD;
      2% before 1990 to 4% since 1990.&#xD;
&#xD;
      Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect&#xD;
      the survival and quality of life of cancer patients.&#xD;
&#xD;
      Chemotherapy is a regular generator of cytopenia, the most prominent of which is&#xD;
      thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution&#xD;
      shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet&#xD;
      therapy.&#xD;
&#xD;
      In this specific population (i.e., with cancer and hypocoagulability), the occurrence of&#xD;
      thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in&#xD;
      this situation is unknown and the behavior to be poorly specified.&#xD;
&#xD;
      Based on these considerations, The investigator propose a two-year prospective cohort study&#xD;
      to explore the biological parameters of hypocoagulability and to assess the incidence and&#xD;
      prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet&#xD;
      aggregation (AGP) and / or direct oral anticoagulant (AOD).&#xD;
&#xD;
      In this study, the investigator means by hypocoagulability any situation modifying the normal&#xD;
      coagulation system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200&#xD;
      cancer patients, about 5 times higher than in the general population.&#xD;
&#xD;
      These events are of crucial importance, since nearly 10% of cancer patients died from&#xD;
      thromboembolic events (EVT), making them the second leading cause of death in this&#xD;
      population.&#xD;
&#xD;
      In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% -&#xD;
      2% before 1990 to 4% since 1990.&#xD;
&#xD;
      Some studies report an increase in the hospitalization cost of 38%, correlated in part with&#xD;
      the increase in hospitalization duration related to venous thromboembolism.&#xD;
&#xD;
      Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect&#xD;
      the survival and quality of life of cancer patients. Scores were established and validated to&#xD;
      establish this risk and to propose prophylaxis in these patients. Guidelines exist for&#xD;
      prophylaxis and for the treatment of these patients.&#xD;
&#xD;
      Chemotherapy is a regular generator of cytopenia, the most prominent of which is&#xD;
      thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution&#xD;
      shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet&#xD;
      therapy.&#xD;
&#xD;
      In this specific population (i.e., with cancer and hypocoagulability), the occurrence of&#xD;
      thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in&#xD;
      this situation is unknown and the behavior to be poorly specified.&#xD;
&#xD;
      Based on these considerations, The investigator propose a two-year prospective cohort study&#xD;
      to explore the biological parameters of hypocoagulability and to assess the incidence and&#xD;
      prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet&#xD;
      aggregation (AGP) and / or direct oral anticoagulant (AOD).&#xD;
&#xD;
      In this study, the investigator means by hypocoagulability any situation modifying the normal&#xD;
      coagulation system, that is to say:&#xD;
&#xD;
        -  The presence of any anti-coagulant or antiplatelet treatment,&#xD;
&#xD;
        -  Or abnormalities of primary or secondary hemostasis causing coagulation disorders.&#xD;
&#xD;
      Some studies report an increase in the hospitalization cost of 38%, correlated in part with&#xD;
      the increase in hospitalization duration related to venous thromboembolism.&#xD;
&#xD;
      Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect&#xD;
      the survival and quality of life of cancer patients. Scores were established and validated to&#xD;
      establish this risk and to propose prophylaxis in these patients. Guidelines exist for&#xD;
      prophylaxis and for the treatment of these patients.&#xD;
&#xD;
      Chemotherapy is a regular generator of cytopenia, the most prominent of which is&#xD;
      thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution&#xD;
      shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet&#xD;
      therapy.&#xD;
&#xD;
      In this specific population (i.e., with cancer and hypocoagulability), the occurrence of&#xD;
      thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in&#xD;
      this situation is unknown and the behavior to be poorly specified.&#xD;
&#xD;
      Based on these considerations, The investigator propose a two-year prospective cohort study&#xD;
      to explore the biological parameters of hypocoagulability and to assess the incidence and&#xD;
      prevalence of DVT in thrombocytopenic patients on vitamin K antagonists (AVK), anti platelet&#xD;
      aggregation (AGP) and / or direct oral anticoagulant (AOD).&#xD;
&#xD;
      In this study the investigator mean by hypocoagulability any situation modifying the normal&#xD;
      coagulation system, that is to say:&#xD;
&#xD;
        -  the presence of any anti-coagulant or antiplatelet treatment,&#xD;
&#xD;
        -  or abnormalities of primary or secondary hemostasis causing coagulation disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2019</start_date>
  <completion_date type="Actual">September 9, 2022</completion_date>
  <primary_completion_date type="Actual">September 9, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of thrombosis rate in patients hospitalized for cancer</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence rate of first occurrence of thromboembolic event in cancer patients, and hospitalized</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the values of the biological parameters of thrombophilia assessment, blood count and coagulation, at the time of the occurrence of thrombosis, between patients in a situation of hypocoagulability and patients with no hypocoagulability.</measure>
    <time_frame>12 months</time_frame>
    <description>These patients in these two situations, will be identified, during the onset of thrombosis, the results of the parameters of their blood count and their intake of antiaggregant or anticoagulant treatment.&#xD;
• Comparison between the hypocoagulable patient group and the non-hypocoagulable patient group of the biological parameters of the thrombophilia balance, blood counts and coagulation counts in patients with cancer at the time of the occurrence of thrombosis&#xD;
o The state of hypocoagulability is defined by: thrombocytopenia &lt;100000 / mm3, abnormality of one or more coagulation factors, platelet antiaggregant treatment, anticoagulant treatment of all kinds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of thrombosis rate with new oral anticoagulants.</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence rate of first occurrence of thromboembolic events in patients with cancer, and treatment with new oral anticoagulants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of 12-month survival of patients with or without hypocoagulability, with thrombosis.</measure>
    <time_frame>12 months</time_frame>
    <description>Survival at 12 months. 12-month survival is defined as the delay between the date of inclusion and the date of death from all causes. Patients lost to follow-up will be censored on the date of the latest news. Patients will be followed for 12 months after inclusion in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Determination of death rate due to thrombosis.</measure>
    <time_frame>12 months</time_frame>
    <description>Death rate due to thrombosis is the number of deaths whose cause is thrombosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of the rate of hemorrhagic complications in this population.</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of haemorrhagic complications defined by the number of haemorrhagic events, whatever the degree of severity, of biological or medicinal origin.&#xD;
o A haemorrhagic event is defined as the occurrence of bleeding by rupture of a blood vessel or effusion out of a blood vessel. Bleeding may be internal or external, see the examples provided below: Internal haemorrhage: cerebral hematoma, subdural hematoma; intramuscular hematoma&#xD;
- Externalized hemorrhage: epistaxis, gingivorrhagia, externalized digestive bleeding</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">700</enrollment>
  <condition>Neoplasms</condition>
  <condition>Thrombosis</condition>
  <condition>Coagulation Disorder</condition>
  <arm_group>
    <arm_group_label>Experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hospitalized patient</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sample analysis</intervention_name>
    <description>Thrombophilia, blood count and coagulation count</description>
    <arm_group_label>Experimental arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient followed for CAL cancer and admitted to the LTC in the Medicine Department.&#xD;
&#xD;
          2. Age&gt; to 18 years.&#xD;
&#xD;
          3. Patient having read the information note and signed the informed consent (including&#xD;
             specific consent for genotyping of clotting factors).&#xD;
&#xD;
          4. Patient receiving social insurance.&#xD;
&#xD;
          5. Weight&gt; 50kg&#xD;
&#xD;
          6. Hemoglobin level&gt; 7.0 g / dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient not benefiting as part of his treatment from hospitalization, but admitted on&#xD;
             an ambulatory basis.&#xD;
&#xD;
          2. Patient whose age is less than 18 years.&#xD;
&#xD;
          3. Patient already included in the study.&#xD;
&#xD;
          4. Patient considered a vulnerable person; Vulnerable people are defined in Article&#xD;
             L1121-5 to -8:&#xD;
&#xD;
               -  Pregnant women, parturients and breastfeeding mothers&#xD;
&#xD;
               -  Persons deprived of their liberty by a judicial or administrative decision,&#xD;
                  persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who&#xD;
                  do not fall under the provisions of Article L. 1121-8&#xD;
&#xD;
               -  and persons admitted to a health or social institution for purposes other than&#xD;
                  research&#xD;
&#xD;
               -  adults who are legally protected or unable to express their consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>December 12, 2022</last_update_submitted>
  <last_update_submitted_qc>December 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neoplasms, Thrombosis, hypocoagulability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03826043
org study id: 2018/23
nct id: NCT03826043
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200
      cancer patients, about 5 times higher than in the general population.

      These events are of crucial importance, since nearly 10% of cancer patients died from
      thromboembolic events (EVT), making them the second leading cause of death in this
      population.

      In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% -
      2% before 1990 to 4% since 1990.

      Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect
      the survival and quality of life of cancer patients.

      Chemotherapy is a regular generator of cytopenia, the most prominent of which is
      thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution
      shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet
      therapy.

      In this specific population (i.e., with cancer and hypocoagulability), the occurrence of
      thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in
      this situation is unknown and the behavior to be poorly specified.

      Based on these considerations, The investigator propose a two-year prospective cohort study
      to explore the biological parameters of hypocoagulability and to assess the incidence and
      prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet
      aggregation (AGP) and / or direct oral anticoagulant (AOD).

      In this study, the investigator means by hypocoagulability any situation modifying the normal
      coagulation system.
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200
      cancer patients, about 5 times higher than in the general population.

      These events are of crucial importance, since nearly 10% of cancer patients died from
      thromboembolic events (EVT), making them the second leading cause of death in this
      population.

      In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% -
      2% before 1990 to 4% since 1990.

      Some studies report an increase in the hospitalization cost of 38%, correlated in part with
      the increase in hospitalization duration related to venous thromboembolism.

      Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect
      the survival and quality of life of cancer patients. Scores were established and validated to
      establish this risk and to propose prophylaxis in these patients. Guidelines exist for
      prophylaxis and for the treatment of these patients.

      Chemotherapy is a regular generator of cytopenia, the most prominent of which is
      thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution
      shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet
      therapy.

      In this specific population (i.e., with cancer and hypocoagulability), the occurrence of
      thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in
      this situation is unknown and the behavior to be poorly specified.

      Based on these considerations, The investigator propose a two-year prospective cohort study
      to explore the biological parameters of hypocoagulability and to assess the incidence and
      prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet
      aggregation (AGP) and / or direct oral anticoagulant (AOD).

      In this study, the investigator means by hypocoagulability any situation modifying the normal
      coagulation system, that is to say:

        -  The presence of any anti-coagulant or antiplatelet treatment,

        -  Or abnormalities of primary or secondary hemostasis causing coagulation disorders.

      Some studies report an increase in the hospitalization cost of 38%, correlated in part with
      the increase in hospitalization duration related to venous thromboembolism.

      Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect
      the survival and quality of life of cancer patients. Scores were established and validated to
      establish this risk and to propose prophylaxis in these patients. Guidelines exist for
      prophylaxis and for the treatment of these patients.

      Chemotherapy is a regular generator of cytopenia, the most prominent of which is
      thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution
      shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet
      therapy.

      In this specific population (i.e., with cancer and hypocoagulability), the occurrence of
      thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in
      this situation is unknown and the behavior to be poorly specified.

      Based on these considerations, The investigator propose a two-year prospective cohort study
      to explore the biological parameters of hypocoagulability and to assess the incidence and
      prevalence of DVT in thrombocytopenic patients on vitamin K antagonists (AVK), anti platelet
      aggregation (AGP) and / or direct oral anticoagulant (AOD).

      In this study the investigator mean by hypocoagulability any situation modifying the normal
      coagulation system, that is to say:

        -  the presence of any anti-coagulant or antiplatelet treatment,

        -  or abnormalities of primary or secondary hemostasis causing coagulation disorders.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Evaluation of thrombosis rate in patients hospitalized for cancer
time frame: 12 months
description: Incidence rate of first occurrence of thromboembolic event in cancer patients, and hospitalized
measure: Comparison of the values of the biological parameters of thrombophilia assessment, blood count and coagulation, at the time of the occurrence of thrombosis, between patients in a situation of hypocoagulability and patients with no hypocoagulability.
time frame: 12 months
description: These patients in these two situations, will be identified, during the onset of thrombosis, the results of the parameters of their blood count and their intake of antiaggregant or anticoagulant treatment.
• Comparison between the hypocoagulable patient group and the non-hypocoagulable patient group of the biological parameters of the thrombophilia balance, blood counts and coagulation counts in patients with cancer at the time of the occurrence of thrombosis
o The state of hypocoagulability is defined by: thrombocytopenia <100000 / mm3, abnormality of one or more coagulation factors, platelet antiaggregant treatment, anticoagulant treatment of all kinds.
measure: Determination of thrombosis rate with new oral anticoagulants.
time frame: 12 months
description: Incidence rate of first occurrence of thromboembolic events in patients with cancer, and treatment with new oral anticoagulants
measure: Comparison of 12-month survival of patients with or without hypocoagulability, with thrombosis.
time frame: 12 months
description: Survival at 12 months. 12-month survival is defined as the delay between the date of inclusion and the date of death from all causes. Patients lost to follow-up will be censored on the date of the latest news. Patients will be followed for 12 months after inclusion in the study.
measure: • Determination of death rate due to thrombosis.
time frame: 12 months
description: Death rate due to thrombosis is the number of deaths whose cause is thrombosis.
measure: Determination of the rate of hemorrhagic complications in this population.
time frame: 12 months
description: Rate of haemorrhagic complications defined by the number of haemorrhagic events, whatever the degree of severity, of biological or medicinal origin.
o A haemorrhagic event is defined as the occurrence of bleeding by rupture of a blood vessel or effusion out of a blood vessel. Bleeding may be internal or external, see the examples provided below: Internal haemorrhage: cerebral hematoma, subdural hematoma; intramuscular hematoma
- Externalized hemorrhage: epistaxis, gingivorrhagia, externalized digestive bleeding
arm group label: Experimental arm
arm group type: Experimental
description: Hospitalized patient
intervention type: Diagnostic Test
intervention name: Blood sample analysis
description: Thrombophilia, blood count and coagulation count
arm group label: Experimental arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Hemostatic Disorders
mesh term: Thromboembolism
mesh term: Blood Coagulation Disorders
sharing ipd: No