<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/NCT04481152</url>
  </required_header>
  <id_info>
    <org_study_id>APHP191007</org_study_id>
    <secondary_id>2020-A00567-32</secondary_id>
    <nct_id>NCT04481152</nct_id>
  </id_info>
  <brief_title>Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx Paraganglioma</brief_title>
  <acronym>PGL-EXPO-1</acronym>
  <official_title>Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas, Pilot Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ANSES</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 main objective of the pilot phase of PGLEXPO will be to assess the faisability and to&#xD;
      precise methodology of a case-control study designed for testing the impact of environmental&#xD;
      and professional exposures on the tumoral risk in SDHx-mutation carriers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to&#xD;
      precise methodology of a case-control study designed for testing the impact of environmental&#xD;
      and professional exposures on the tumoral risk in SDHx-mutation carriers.&#xD;
&#xD;
      Patients will be selected from subjects with a mutation in one of the SDHx genes. The cases&#xD;
      will have developed a tumor, while the controls will be tumor-free. Controls will be matched&#xD;
      to the cases according to sex, age and type of gene affected. Past exposures will be sought&#xD;
      through a telephone questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">March 1, 2022</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasability of the protocol of a national case/control study (PGL.EXPO2)</measure>
    <time_frame>2 years</time_frame>
    <description>Successful pairing of 50 cases with 50 controls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of matching cases and controls</measure>
    <time_frame>2 years</time_frame>
    <description>Proportion of cases for which a control could be identified</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of matching cases and controls</measure>
    <time_frame>2 years</time_frame>
    <description>Mean number of controls matching for a case</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Genetic Predisposition</condition>
  <condition>SDH Gene Mutation</condition>
  <condition>Environmental Exposure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        50 cases and 50 controls will be enrolled in a single referral center where they are&#xD;
        regurlarly managed and followed for a SDHx-related tumor risk. They will be matched on&#xD;
        their date of birth&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor&#xD;
&#xD;
          2. Controls: SDHx mutation carriers with no SDHx-related tumor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Incapacity to exercise free and informed consent for the study&#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>Anne-Paule GIMENEZ-ROQUEPLO, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne-Paule GIMENEZ-ROQUEPLO, MD, PhD</last_name>
    <phone>33 1 56 09 38 81</phone>
    <email>anne-paule.gimenez-roqueplo@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexandre BUFFET, MD, PhD</last_name>
    <phone>33 1 56 09 38 81</phone>
    <email>alexandre.buffet@aphp.fr</email>
  </overall_contact_backup>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>January 17, 2022</last_update_submitted>
  <last_update_submitted_qc>January 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 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>Paraganglioma</mesh_term>
    <mesh_term>Genetic Predisposition to Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data (IPD) that underlie results in publication could be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>One year after the last publication</ipd_time_frame>
    <ipd_access_criteria>Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. The founder could be involved in the decision.&#xD;
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.</ipd_access_criteria>
  </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/NCT04481152
org study id: APHP191007
secondary id: 2020-A00567-32
nct id: NCT04481152
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to
      precise methodology of a case-control study designed for testing the impact of environmental
      and professional exposures on the tumoral risk in SDHx-mutation carriers
The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to
      precise methodology of a case-control study designed for testing the impact of environmental
      and professional exposures on the tumoral risk in SDHx-mutation carriers.

      Patients will be selected from subjects with a mutation in one of the SDHx genes. The cases
      will have developed a tumor, while the controls will be tumor-free. Controls will be matched
      to the cases according to sex, age and type of gene affected. Past exposures will be sought
      through a telephone questionnaire.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Feasability of the protocol of a national case/control study (PGL.EXPO2)
time frame: 2 years
description: Successful pairing of 50 cases with 50 controls
measure: Feasibility of matching cases and controls
time frame: 2 years
description: Proportion of cases for which a control could be identified
measure: Ease of matching cases and controls
time frame: 2 years
description: Mean number of controls matching for a case
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne-Paule GIMENEZ-ROQUEPLO, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Anne-Paule GIMENEZ-ROQUEPLO, MD, PhD
phone: 33 1 56 09 38 81
email: anne-paule.gimenez-roqueplo@aphp.fr
last name: Alexandre BUFFET, MD, PhD
phone: 33 1 56 09 38 81
email: alexandre.buffet@aphp.fr
responsible party type: Sponsor
mesh term: Paraganglioma
mesh term: Genetic Predisposition to Disease
sharing ipd: Yes
ipd description: Individual participant data (IPD) that underlie results in publication could be shared.
ipd info type: Study Protocol
ipd time frame: One year after the last publication
ipd access criteria: Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. The founder could be involved in the decision.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.