xml: <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/NCT05974696</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL23_0026</org_study_id>
      <nct_id>NCT05974696</nct_id>
    </id_info>
    <brief_title>A Research Registry on Aggressive PitNETs</brief_title>
    <acronym>RECAPitNETT</acronym>
    <official_title>A Research Registry on Aggressive PitNETs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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>
        To allow the identification of markers, it is necessary to extend research networks more&#xD;
        widely to collect and properly explore aggressive pituitary tumours. The multidisciplinary&#xD;
        consultation meeting (RCP), organised by the reference centre for rare diseases of the&#xD;
        pituitary gland, dedicated to aggressive pituitary tumours and carcinomas (HYPOcare), which&#xD;
        is unique in France and brings together national experts, currently makes it possible to&#xD;
        orientate the management of patients with an aggressive pituitary tumour. With more than 80&#xD;
        patient files discussed since its inception, the patient cohort via the HYPOcare RCP is one&#xD;
        of the largest both nationally and internationally. At present, this data source is only&#xD;
        dedicated to the clinical management of the files without the possibility of carrying out&#xD;
        research work&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">June 15, 2029</completion_date>
    <primary_completion_date type="Anticipated">June 15, 2029</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>Characterisation of aggressiveness of pituitary tumours by tanscriptome analysis</measure>
      <time_frame>3 years</time_frame>
      <description>Molecular and transcriptomic signature of aggressiveness of pituitary tumours predictive of prognosis</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Endocrine Tumor</condition>
    <arm_group>
      <arm_group_label>Patients RECAPitNETT</arm_group_label>
      <description>All adult subjects with pituitary tumours whose file is presented to the national HYPOcare RCP. There is only one group.</description>
    </arm_group>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Anatomopathology samples collected and analysed as part of the routine care of the patient&#xD;
        will be sent for centralised analysis to the Cochin Institute in Paris.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Adult subjects with pituitary tumours whose file is presented to the national HYPOcare RCP.&#xD;
          There is only one group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          -  Inclusion Criteria :&#xD;
  &#xD;
                 -  Patients with a diagnosis of pituitary tumour&#xD;
  &#xD;
                 -  Patients whose file has been presented to the national HYPOcare RCP&#xD;
  &#xD;
            -  Exclusion Criteria :&#xD;
  &#xD;
                 -  Patients objecting to participating in this research&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hospices Civils de Lyon - Groupement Hospitalier Est</name>
        <address>
          <city>Lyon</city>
          <zip>69003</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gérald RAVEROT, PhD - MD</last_name>
        <phone>4 72 11 93 25</phone>
        <phone_ext>+33</phone_ext>
        <email>gerald.raverot@chu-lyon.fr</email>
      </contact>
      <contact_backup>
        <last_name>Laurent VILLENEUVE</last_name>
        <phone>4 78 86 45 36</phone>
        <phone_ext>+33</phone_ext>
        <email>laurent.villeneuve@chu-lyon.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Gérald RAVEROT, PhD - MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Endocrine Tumor</keyword>
    <keyword>Reference centre</keyword>
    <keyword>rare diseases</keyword>
    <keyword>transcriptoms</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endocrine Gland Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974696
  org study id: 69HCL23_0026
  nct id: NCT05974696
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To allow the identification of markers, it is necessary to extend research networks more
        widely to collect and properly explore aggressive pituitary tumours. The multidisciplinary
        consultation meeting (RCP), organised by the reference centre for rare diseases of the
        pituitary gland, dedicated to aggressive pituitary tumours and carcinomas (HYPOcare), which
        is unique in France and brings together national experts, currently makes it possible to
        orientate the management of patients with an aggressive pituitary tumour. With more than 80
        patient files discussed since its inception, the patient cohort via the HYPOcare RCP is one
        of the largest both nationally and internationally. At present, this data source is only
        dedicated to the clinical management of the files without the possibility of carrying out
        research work
  observational model: Cohort
  time perspective: Prospective
  measure: Characterisation of aggressiveness of pituitary tumours by tanscriptome analysis
  time frame: 3 years
  description: Molecular and transcriptomic signature of aggressiveness of pituitary tumours predictive of prognosis
  arm group label: Patients RECAPitNETT
  description: All adult subjects with pituitary tumours whose file is presented to the national HYPOcare RCP. There is only one group.
  Anatomopathology samples collected and analysed as part of the routine care of the patient
        will be sent for centralised analysis to the Cochin Institute in Paris.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Endocrine Gland Neoplasms