<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/NCT03787121</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/17/0378</org_study_id>
    <nct_id>NCT03787121</nct_id>
  </id_info>
  <brief_title>Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers</brief_title>
  <acronym>ECO-THYR</acronym>
  <official_title>Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers : Involvement of Overtreatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and&#xD;
      worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty&#xD;
      percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment&#xD;
      of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an&#xD;
      increase of medical resources consumption and corresponding costs.&#xD;
&#xD;
      The primary aim of this study is to estimate the cost related to different care management&#xD;
      pathway of TC patient during a lifetime period using a multi-state Markov model.&#xD;
&#xD;
      This is a retrospective, observational population based cohort study, using data from a&#xD;
      cohort study of TC patients implemented by the ONCOMIP network which initially aimed to&#xD;
      perform an audit of clinical practices for the management of TC, and from database of the&#xD;
      French social health insurance of Midi-Pyrenees region to calculate observed costs of TC&#xD;
      management during 24 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cost related to the different management pathways of TC patient</measure>
    <time_frame>24 months</time_frame>
    <description>estimate the cost related to the different management pathways of TC patient during a lifetime period using a multi-state Markov model</description>
  </primary_outcome>
  <enrollment type="Actual">361</enrollment>
  <condition>Thyroid Cancer</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>care management pathways</intervention_name>
    <description>different care management pathways, including thyroidectomy, iode 131, hormonal treatment and type of follow up</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The Evathyr database collected by the Oncomip network: Cohort describing the initial&#xD;
        management of 423 patients with TC diagnosed in 2014 and passed in the process of&#xD;
        Multidisciplinary Team Meeting (MTM).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients with a good prognosis of the TC&#xD;
&#xD;
          -  diagnosed in 2014&#xD;
&#xD;
          -  whose medical file discussed in MultiDisciplinary Team Meeting (MDTM) in Midi-Pyrenees&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients whose surgical management was carried out outside Midi Pyrenees are excluded&#xD;
             and other morphological types are excluded (medullar, anaplastic, lymphomas, sarcomas)&#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>Nadège Costa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University HospitalToulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>August 26, 2021</last_update_submitted>
  <last_update_submitted_qc>August 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>health economics</keyword>
  <keyword>care management pathways</keyword>
  <keyword>overtreatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT03787121
org study id: RC31/17/0378
nct id: NCT03787121
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and
      worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty
      percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment
      of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an
      increase of medical resources consumption and corresponding costs.

      The primary aim of this study is to estimate the cost related to different care management
      pathway of TC patient during a lifetime period using a multi-state Markov model.

      This is a retrospective, observational population based cohort study, using data from a
      cohort study of TC patients implemented by the ONCOMIP network which initially aimed to
      perform an audit of clinical practices for the management of TC, and from database of the
      French social health insurance of Midi-Pyrenees region to calculate observed costs of TC
      management during 24 months.
observational model: Cohort
time perspective: Retrospective
measure: cost related to the different management pathways of TC patient
time frame: 24 months
description: estimate the cost related to the different management pathways of TC patient during a lifetime period using a multi-state Markov model
intervention type: Procedure
intervention name: care management pathways
description: different care management pathways, including thyroidectomy, iode 131, hormonal treatment and type of follow up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nadège Costa, PhD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
sharing ipd: No