<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/NCT02997384</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01082-49</org_study_id>
    <secondary_id>2016/2422</secondary_id>
    <nct_id>NCT02997384</nct_id>
  </id_info>
  <brief_title>Feasibility of Breast Cancer Risk Evaluation in Women From the General Population</brief_title>
  <acronym>RIVIERA</acronym>
  <official_title>Feasibility of Breast Cancer Risk Evaluation in Women From the General Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to&#xD;
      informing women about their risk of breast cancer and the screening methods recommended for&#xD;
      them according to the recommendations in force during a routine consultation at a general&#xD;
      practitioner, a gynecologist or a radiologist.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation</measure>
    <time_frame>up to 1 year</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Breastcancer</condition>
  <arm_group>
    <arm_group_label>General practitioner</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>gynecologist</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>radiologist</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information</intervention_name>
    <description>information of women about their risk of breast cancer and the screening methods recommended for them</description>
    <arm_group_label>General practitioner</arm_group_label>
    <arm_group_label>gynecologist</arm_group_label>
    <arm_group_label>radiologist</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women 40 to 74 years seen in consultation by their attending physician, gynecologist or&#xD;
        radiologist&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman from 40 to 74 years old&#xD;
&#xD;
          -  Understanding the French language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Women will not be eligible for study if they are in any of the following situations:&#xD;
&#xD;
          -  Cancer active or in the course of treatment type surgery, chemotherapy, or&#xD;
             radiotherapy, whether breast or other organ&#xD;
&#xD;
          -  Recent diagnosis &lt;1 year of suspicious or cancerous lesions&#xD;
&#xD;
          -  Psychiatric pathology not compatible with the study&#xD;
&#xD;
          -  Poor understanding of the French language&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val de Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</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>Breast Neoplasms</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/NCT02997384
org study id: 2016-A01082-49
secondary id: 2016/2422
nct id: NCT02997384
lead sponsor: 
has dmc: No
This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to
      informing women about their risk of breast cancer and the screening methods recommended for
      them according to the recommendations in force during a routine consultation at a general
      practitioner, a gynecologist or a radiologist.
observational model: Cohort
time perspective: Prospective
measure: Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation
time frame: up to 1 year
arm group label: General practitioner
arm group label: gynecologist
arm group label: radiologist
intervention type: Other
intervention name: Information
description: information of women about their risk of breast cancer and the screening methods recommended for them
arm group label: General practitioner
arm group label: gynecologist
arm group label: radiologist
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No