<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/NCT03749681</url>
  </required_header>
  <id_info>
    <org_study_id>TANGO (29BRC18.0013)</org_study_id>
    <nct_id>NCT03749681</nct_id>
  </id_info>
  <brief_title>Neuroendocrine Tumors of Old Patients in the West of France</brief_title>
  <acronym>TANGO</acronym>
  <official_title>Neuroendocrine Tumors of Patients Aged of 75 y or Over in the West of France</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Brest</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>
      Neuroendocrine cancer remains a poorly known entity. Comprehensive treatment is&#xD;
      multidisciplinary involving surgery, radiological and nuclear medicine, and medical. A&#xD;
      national network for the management of sporadic and hereditary malignant neuro-ENdocrine&#xD;
      Tumor (RENATEN) is in charged of coordinating this specific care. This is part of the French&#xD;
      National Cancer INstitute (INCa) Rare Cancer Plan.&#xD;
&#xD;
      The project is in the form of an analysis of elderly population (75 years or over) with a&#xD;
      diagnosis of neuroendocrine cancer in the western part of the France (Brittany, Pays de&#xD;
      Loire, Normandy, Center and a part of New Aquitaine areas) representing a population of more&#xD;
      than 12 millions of inhabitants. Oncogeriatric evaluations, specialized meetings, ...would be&#xD;
      analysed in order to improve the care of rare cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">March 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 28, 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>Tumor description : localization of the tumor (digestive or others) provided by scan or anatomopathologic report</measure>
    <time_frame>03/31/2020</time_frame>
    <description>statistical analysis (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All anticancer treatment description in neuroendocrine tumors of 3 specific histological grade (G1, 2 or 3)</measure>
    <time_frame>03/31/2020</time_frame>
    <description>statistical analysis (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Histology, differentiation status</measure>
    <time_frame>03/31/2020</time_frame>
    <description>qualitative description (text)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mitotic index and proliferation idex of the tumor</measure>
    <time_frame>03/31/2020</time_frame>
    <description>statistical analysis (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response rate</measure>
    <time_frame>03/31/2020</time_frame>
    <description>statistical analysis (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>progression free survival</measure>
    <time_frame>03/31/2020</time_frame>
    <description>statistical analysis (months) with Kaplan meier analysis; data provided by the medical file</description>
  </primary_outcome>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>03/31/2020</time_frame>
    <description>statistical analysis (months) with Kaplan meier analysis; data provided by the medical file</description>
  </primary_outcome>
  <enrollment type="Anticipated">306</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly patients with a neuroendocrine tumor whose medical file was analysed by RENATEN&#xD;
        group between 2014 and 2017 in 4 western regions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  75 years old or over at the time of diagnosis&#xD;
&#xD;
          -  Patient with G1/G2/G3 neuroendocrine tumor diagnosed by pathological analysis&#xD;
&#xD;
          -  Patient whose medical file was examined by RENATEN (National Network for the treatment&#xD;
             of neuro-ENdocrine sporadic and hereditary disease Tumor) meetings or other&#xD;
             multidisciplinary consultation meeting between 01/01/2014 and 31/12/2017&#xD;
&#xD;
          -  Patient with care in private and public centers in the West of France&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with cancer other than a neuroendocrine tumor&#xD;
&#xD;
          -  Patient with a G4 neuroendocrine tumor&#xD;
&#xD;
          -  Patient who has objected to the study and collection of his medical data&#xD;
&#xD;
          -  Refusal of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jean-Philippe METGES</last_name>
    <phone>02-98-22-33-62</phone>
    <email>jean-philippe.metges@chu-brest.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Delphine DENIEL LAGADEC</last_name>
    <phone>+33 2 98 22 39 80</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Jean-Philippe Metges</last_name>
      <email>jean-philippe.metges@chu-brest.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>April 5, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuroendocrine Tumors</keyword>
  <keyword>75 y and over patients</keyword>
  <keyword>Oncogeriatric follow-up</keyword>
  <keyword>Oncologic care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroendocrine Tumors</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/NCT03749681
org study id: TANGO (29BRC18.0013)
nct id: NCT03749681
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neuroendocrine cancer remains a poorly known entity. Comprehensive treatment is
      multidisciplinary involving surgery, radiological and nuclear medicine, and medical. A
      national network for the management of sporadic and hereditary malignant neuro-ENdocrine
      Tumor (RENATEN) is in charged of coordinating this specific care. This is part of the French
      National Cancer INstitute (INCa) Rare Cancer Plan.

      The project is in the form of an analysis of elderly population (75 years or over) with a
      diagnosis of neuroendocrine cancer in the western part of the France (Brittany, Pays de
      Loire, Normandy, Center and a part of New Aquitaine areas) representing a population of more
      than 12 millions of inhabitants. Oncogeriatric evaluations, specialized meetings, ...would be
      analysed in order to improve the care of rare cancer patients.
observational model: Cohort
time perspective: Retrospective
measure: Tumor description : localization of the tumor (digestive or others) provided by scan or anatomopathologic report
time frame: 03/31/2020
description: statistical analysis (%)
measure: All anticancer treatment description in neuroendocrine tumors of 3 specific histological grade (G1, 2 or 3)
time frame: 03/31/2020
description: statistical analysis (%)
measure: Histology, differentiation status
time frame: 03/31/2020
description: qualitative description (text)
measure: mitotic index and proliferation idex of the tumor
time frame: 03/31/2020
description: statistical analysis (%)
measure: Response rate
time frame: 03/31/2020
description: statistical analysis (%)
measure: progression free survival
time frame: 03/31/2020
description: statistical analysis (months) with Kaplan meier analysis; data provided by the medical file
measure: overall survival
time frame: 03/31/2020
description: statistical analysis (months) with Kaplan meier analysis; data provided by the medical file
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Philippe METGES
phone: 02-98-22-33-62
email: jean-philippe.metges@chu-brest.fr
last name: Delphine DENIEL LAGADEC
phone: +33 2 98 22 39 80
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors
sharing ipd: No