<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/NCT03292107</url>
  </required_header>
  <id_info>
    <org_study_id>Management Thrombosis</org_study_id>
    <nct_id>NCT03292107</nct_id>
  </id_info>
  <brief_title>Study on Management Thrombosis in Greek Cancer Patients</brief_title>
  <acronym>GMaT</acronym>
  <official_title>Study on Management Thrombosis in Greek Cancer Patients (GMaT - Greek Management Thrombosis)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hellenic Society of Medical Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hellenic Society of Medical Oncology</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>
      Study on Management Thrombosis in Greek cancer patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The approach that Medical Oncologists encounter the prospect of a coagulation event&#xD;
      occurrence in cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>The clinical practice for patients under anticoagulation regime</measure>
    <time_frame>1 YEAR</time_frame>
    <description>Documentation of the clinical practice for patients under anticoagulation regime, for prophylaxis or treatment, in patients with solid tumors, for one year following the protocol initiation date, including high-risk patients as defined in the protocol.</description>
  </primary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Thrombosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with solid tumors under anticoagulation regime, for prophylaxis or treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  All patients diagnosed with histologically confirmed solid tumors that are under&#xD;
             anticoagulation therapy, during the study timeline.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Initiation of anticoagulation therapy before the initiation of the study in 2016&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  No signed informed 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>
  <overall_official>
    <last_name>Ioannis Varthalitis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hellenic Society of Medical Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hellenic Society of Medical Oncology</name>
      <address>
        <city>Athens</city>
        <zip>11475</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</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>Thrombosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03292107
org study id: Management Thrombosis
nct id: NCT03292107
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study on Management Thrombosis in Greek cancer patients
The approach that Medical Oncologists encounter the prospect of a coagulation event
      occurrence in cancer patients.
observational model: Cohort
time perspective: Prospective
measure: The clinical practice for patients under anticoagulation regime
time frame: 1 YEAR
description: Documentation of the clinical practice for patients under anticoagulation regime, for prophylaxis or treatment, in patients with solid tumors, for one year following the protocol initiation date, including high-risk patients as defined in the protocol.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ioannis Varthalitis, MD
role: Principal Investigator
affiliation: Hellenic Society of Medical Oncology
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Thrombosis