<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/NCT03765333</url>
  </required_header>
  <id_info>
    <org_study_id>REGETNE-Tiroides</org_study_id>
    <nct_id>NCT03765333</nct_id>
  </id_info>
  <brief_title>GETNE Registration of Thyroid Cancer</brief_title>
  <official_title>Descriptive Observational Epidemiological Study on the Characteristics of Thyroid Cancer in Patients Treated in Oncology Services of Spanish Centers: National Registry of Thyroid Cancer - Differentiated, Medullary and Anaplastic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Espanol de Tumores Neuroendocrinos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo Espanol de Tumores Neuroendocrinos</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>
      An epidemiological, observational, multicenter, cross-sectional, retrospective study on&#xD;
      patients ≥ 18 years visited in the oncology services of the participating centers with&#xD;
      diagnosis of primary thyroid cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hystopathological characteristics of the tumor</measure>
    <time_frame>Baseline</time_frame>
    <description>Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Situation of the tumor at first-diagnosis</measure>
    <time_frame>Baseline</time_frame>
    <description>Local tumor, locoregional tumor or metastatic disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor-Node-Metastasis classification</measure>
    <time_frame>Baseline</time_frame>
    <description>Based on the AJCC (American Joint Committee on Cancer) 2018 TNM system: T for extent or size of the tumor, N for lymph nodes spread and M for metastasis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor Stage</measure>
    <time_frame>Baseline</time_frame>
    <description>From I to IV, based on the interpretation of the TNM classification and depending on the hystopathological characteristics of the tumor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient situation at the end of treatment</measure>
    <time_frame>12 months</time_frame>
    <description>Results of clinical evaluation of the disease including complete response, partial response, stable disease, progression of disease or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with BRAF mutation</measure>
    <time_frame>12 months</time_frame>
    <description>Total patients with available results on BRAF status and proportion of patients with mutated BRAF or native BRAF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with RET mutation</measure>
    <time_frame>12 months</time_frame>
    <description>Total patients with available results on RET status and proportion of patients with mutated RET or native RET.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with PI3K mutation</measure>
    <time_frame>12 months</time_frame>
    <description>Total patients with available results on PI3K status and proportion of patients with mutated PI3K or native PI3K.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with RAS mutation</measure>
    <time_frame>12 months</time_frame>
    <description>Total patients with available results on RAS status and proportion of patients with mutated RAS or native RAS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with PAX8/PAR mutation</measure>
    <time_frame>12 months</time_frame>
    <description>Total patients with available results on PAX8/PAR status and proportion of patients with mutated PAX8/PAR or native PAX8/PAR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with P53 mutation</measure>
    <time_frame>12 months</time_frame>
    <description>Total patients with available results on P53 status and proportion of patients with mutated P53 or native P53.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with PTEN mutation</measure>
    <time_frame>12 months</time_frame>
    <description>Total patients with available results on PTEN status and proportion of patients with mutated PTEN or native PTEN.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Thyroid Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients ≥ 18 years visited in the oncology services of the participating centers that have&#xD;
        a diagnosis of primary cancer located in the thyroid gland.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years with diagnosis of differentiated, medullary or anaplastic&#xD;
             thyroid cancer confirmed by histopathology.&#xD;
&#xD;
          -  Patients who agree to participate and are able to understand the information sheet and&#xD;
             sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age.&#xD;
&#xD;
          -  Patients with other types of thyroid cancer or whose histopathological diagnosis has&#xD;
             not been confirmed.&#xD;
&#xD;
          -  Patients who do not have the relevant basic information to be included in the study,&#xD;
             according to the criteria of the principal investigator.&#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>Jorge Hernando Cubero, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitari Vall d'Hebron, Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaume Capdevila, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitari Vall d'Hebron, Barcelona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Secretaria Técnica GETNE</last_name>
    <phone>+34 93 434 44 12</phone>
    <email>getne@mfar.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor, M.D.</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
    <investigator>
      <last_name>Principal investigator selected by the sponsor, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</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>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/NCT03765333
org study id: REGETNE-Tiroides
nct id: NCT03765333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An epidemiological, observational, multicenter, cross-sectional, retrospective study on
      patients ≥ 18 years visited in the oncology services of the participating centers with
      diagnosis of primary thyroid cancer.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Hystopathological characteristics of the tumor
time frame: Baseline
description: Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.
measure: Situation of the tumor at first-diagnosis
time frame: Baseline
description: Local tumor, locoregional tumor or metastatic disease.
measure: Tumor-Node-Metastasis classification
time frame: Baseline
description: Based on the AJCC (American Joint Committee on Cancer) 2018 TNM system: T for extent or size of the tumor, N for lymph nodes spread and M for metastasis.
measure: Tumor Stage
time frame: Baseline
description: From I to IV, based on the interpretation of the TNM classification and depending on the hystopathological characteristics of the tumor.
measure: Patient situation at the end of treatment
time frame: 12 months
description: Results of clinical evaluation of the disease including complete response, partial response, stable disease, progression of disease or death
measure: Number of patients with BRAF mutation
time frame: 12 months
description: Total patients with available results on BRAF status and proportion of patients with mutated BRAF or native BRAF.
measure: Number of patients with RET mutation
time frame: 12 months
description: Total patients with available results on RET status and proportion of patients with mutated RET or native RET.
measure: Number of patients with PI3K mutation
time frame: 12 months
description: Total patients with available results on PI3K status and proportion of patients with mutated PI3K or native PI3K.
measure: Number of patients with RAS mutation
time frame: 12 months
description: Total patients with available results on RAS status and proportion of patients with mutated RAS or native RAS.
measure: Number of patients with PAX8/PAR mutation
time frame: 12 months
description: Total patients with available results on PAX8/PAR status and proportion of patients with mutated PAX8/PAR or native PAX8/PAR.
measure: Number of patients with P53 mutation
time frame: 12 months
description: Total patients with available results on P53 status and proportion of patients with mutated P53 or native P53.
measure: Number of patients with PTEN mutation
time frame: 12 months
description: Total patients with available results on PTEN status and proportion of patients with mutated PTEN or native PTEN.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jorge Hernando Cubero, M.D.
role: Study Director
affiliation: Hospital Universitari Vall d'Hebron, Barcelona
last name: Jaume Capdevila, M.D.
role: Study Chair
affiliation: Hospital Universitari Vall d'Hebron, Barcelona
last name: Secretaria Técnica GETNE
phone: +34 93 434 44 12
email: getne@mfar.net
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
sharing ipd: No