<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/NCT02185560</url>
  </required_header>
  <id_info>
    <org_study_id>17391</org_study_id>
    <secondary_id>NEXAVAR-TC-01</secondary_id>
    <nct_id>NCT02185560</nct_id>
  </id_info>
  <brief_title>Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib</brief_title>
  <acronym>JPMS-DTC</acronym>
  <official_title>Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a non-interventional, multi center post-authorization safety study that includes all&#xD;
      patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with&#xD;
      Sorafenib within a certain period. The investigator should have made the choice of treatment&#xD;
      (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this&#xD;
      study.&#xD;
&#xD;
      The enrollment period is of 9 months. The observation period for each patient starts when the&#xD;
      therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no&#xD;
      longer possible (e.g. lost to follow-up); this will be considered the standard observation&#xD;
      period. Those patients, to whom a total of 24 month follow up is possible, information on&#xD;
      effectiveness including treatment duration and survival status of the patient and of&#xD;
      keratoacanthoma and/or squamous cell cancer development will be collected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 27, 2014</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Actual">February 27, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with Adverse drug reaction as a measure of safety and tolerability.</measure>
    <time_frame>Up to 9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with Serious adverse events as a measure of safety and tolerability.</measure>
    <time_frame>Up to 9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with Serious adverse drug reaction as a measure of safety and tolerability</measure>
    <time_frame>Up to 9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>2-year survival</measure>
    <time_frame>At 24 months</time_frame>
    <description>Percentage of participants who survived 2 years from start of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of treatment failure (TTF)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of permanent discontinuation for any reason including disease progression, adverse event, patient preference or death.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">453</enrollment>
  <condition>Thyroid Carcinoma</condition>
  <arm_group>
    <arm_group_label>BAY43-9006</arm_group_label>
    <description>NEXAVAR treatment group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sorafenib (Nexavar, BAY43-9006)</intervention_name>
    <description>Patients treated by Physician with Nexavar under approved local prescriptions</description>
    <arm_group_label>BAY43-9006</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with Sorafenib for Unresectable Differentiated Thyroid Carcinoma (DTC)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who start NEXAVAR treatment for radioactive iodine-refractory unresectable&#xD;
             Differentiated Thyroid Carcinoma (DTC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have already received NEXAVAR treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>August 25, 2023</last_update_submitted>
  <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sorafenib</keyword>
  <keyword>Differentiated Thyroid Carcinoma,</keyword>
  <keyword>Japan</keyword>
  <keyword>Post Marketing Surveillance</keyword>
  <keyword>Drug Use Investigation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sorafenib</mesh_term>
  </intervention_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/NCT02185560
org study id: 17391
secondary id: NEXAVAR-TC-01
nct id: NCT02185560
lead sponsor: 
has dmc: No
This is a non-interventional, multi center post-authorization safety study that includes all
      patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with
      Sorafenib within a certain period. The investigator should have made the choice of treatment
      (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this
      study.

      The enrollment period is of 9 months. The observation period for each patient starts when the
      therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no
      longer possible (e.g. lost to follow-up); this will be considered the standard observation
      period. Those patients, to whom a total of 24 month follow up is possible, information on
      effectiveness including treatment duration and survival status of the patient and of
      keratoacanthoma and/or squamous cell cancer development will be collected.
observational model: Cohort
time perspective: Other
measure: Number of participants with Adverse drug reaction as a measure of safety and tolerability.
time frame: Up to 9 months
measure: Number of participants with Serious adverse events as a measure of safety and tolerability.
time frame: Up to 9 months
measure: Number of participants with Serious adverse drug reaction as a measure of safety and tolerability
time frame: Up to 9 months
measure: 2-year survival
time frame: At 24 months
description: Percentage of participants who survived 2 years from start of treatment
measure: Time of treatment failure (TTF)
time frame: Up to 24 months
description: Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of permanent discontinuation for any reason including disease progression, adverse event, patient preference or death.
arm group label: BAY43-9006
description: NEXAVAR treatment group
intervention type: Drug
intervention name: Sorafenib (Nexavar, BAY43-9006)
description: Patients treated by Physician with Nexavar under approved local prescriptions
arm group label: BAY43-9006
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Japan
url: http://clinicaltrials.bayer.com/
description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
mesh term: Sorafenib