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/NCT05996289</url>
    </required_header>
    <id_info>
      <org_study_id>29BRC23.0145 - VARIOP</org_study_id>
      <nct_id>NCT05996289</nct_id>
    </id_info>
    <brief_title>Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI (VARIOP)</brief_title>
    <acronym>VARIOP</acronym>
    <official_title>Inter-observer Variability in the Segmentation of Prostate Tumour Lesions Using Multiparametric MRI</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Brest</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        Following the major technological and scientific advances in external radiotherapy in recent&#xD;
        decades, thanks to the use of three-dimensional conformal techniques combined with intensity&#xD;
        modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without&#xD;
        increasing sequelae and complications, giving rise to the term &quot;dose escalation&quot;.&#xD;
  &#xD;
        Following multiple dose-escalation clinical trials showing better biological control of PSA,&#xD;
        the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost&#xD;
        in relation to the primary prostate lesion, considered to be the preferred site of neoplastic&#xD;
        recurrence in prostate cancer.&#xD;
  &#xD;
        This leads to the first question, which concerns the identification of the dominant lesion&#xD;
        and its precise delimitation. This last point is subject to variation between operators. A&#xD;
        retrospective cohort from the Finistère region will therefore be used to develop a number of&#xD;
        study points relating to :&#xD;
  &#xD;
        inter-operator contour variability&#xD;
  &#xD;
          -  Factors influencing contour&#xD;
  &#xD;
          -  Impact of contour variability on dosimetry&#xD;
  &#xD;
          -  Automatic segmentation&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Following the major technological and scientific advances in external radiotherapy in recent&#xD;
        decades, thanks to the use of three-dimensional conformal techniques combined with intensity&#xD;
        modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without&#xD;
        increasing sequelae and complications, giving rise to the term &quot;dose escalation&quot;.&#xD;
  &#xD;
        Following multiple dose-escalation clinical trials showing better biological control of PSA,&#xD;
        the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost&#xD;
        in relation to the primary prostate lesion, considered to be the preferred site of neoplastic&#xD;
        recurrence in prostate cancer.&#xD;
  &#xD;
        One of the issues raised by such a study is the methodology used to contour the tumour&#xD;
        lesion, an issue which concerns the whole field of radiotherapy. The reference imaging&#xD;
        technique for diagnosing prostate cancer, and more specifically the dominant tumour lesion,&#xD;
        is multiparametric Magnetic Resonance Imaging. This leads to the first question, which&#xD;
        concerns the identification of the dominant lesion and its precise delimitation. This last&#xD;
        point is subject to variation between operators. A retrospective cohort from the Finistère&#xD;
        region will therefore be used to develop a number of study points relating to :&#xD;
  &#xD;
        inter-operator contour variability&#xD;
  &#xD;
          -  Factors influencing contour&#xD;
  &#xD;
          -  Impact of contour variability on dosimetry&#xD;
  &#xD;
          -  Automatic segmentation&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</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>Inter-observer variability</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>The main criterion for judging inter-observer variability is the spatial overlap of contours on mpMRI, represented by the DICE similarity coefficient, which ranges from 0 to 1, where 1 represents zero variability between contours of the same lesion.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical factors influencing inter-observer variability.</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>Subgroup analysis of radio-clinical-histological factors likely to influence inter-observer variability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing inter-sequence reproducibility</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>Assessing inter-sequence reproducibility</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dosimetric impact of Inter-observer variability</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>The influence of variability on dosimetry in IMRT/VMAT conformal radiotherapy.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Automatic segmentation of prostatic tumors</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>Contour variability using a deep-learning automated segmentation technique, with and without implementation of factors identified as impacting contour in manual technique.</description>
    </other_outcome>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Prostate Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patient treated or being treated for prostatic adenocarcinoma&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Histologically proven localized prostatic neoplasia on trans-rectal biopsies.&#xD;
  &#xD;
            -  Multiparametric prostate MRI performed prior to prostate biopsies.&#xD;
  &#xD;
            -  No opposition expressed&#xD;
  &#xD;
            -  Patient affiliated to a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of surgery, prostatic irradiation or hormonal treatment prior to diagnosis.&#xD;
  &#xD;
            -  History of prostate cancer&#xD;
  &#xD;
            -  No identifiable target lesion on mpMRI (&lt;PIRADS 3)&#xD;
  &#xD;
            -  Opposition formulated&#xD;
  &#xD;
            -  Patient under legal protection (guardianship, curatorship, etc.)&#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>Vincent Bourbonne, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Radiation Oncology Department, Brest University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vincent BOURBONNE, MD, PhD</last_name>
      <phone>+33298223398</phone>
      <email>vincent.bourbonne@chu-brest.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chu Brest</name>
        <address>
          <city>Brest</city>
          <zip>29609</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vincent Bourbonne, MD, PhD</last_name>
        <phone>+33298223398</phone>
        <email>vincent.bourbonne@chu-brest.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>radiotherapy</keyword>
    <keyword>MRI</keyword>
    <keyword>segmentation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All collected data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data will be available beginning three years and ending fifteen years following the final study report completion</ipd_time_frame>
      <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05996289
  org study id: 29BRC23.0145 - VARIOP
  nct id: NCT05996289
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Following the major technological and scientific advances in external radiotherapy in recent
        decades, thanks to the use of three-dimensional conformal techniques combined with intensity
        modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without
        increasing sequelae and complications, giving rise to the term "dose escalation".
  
        Following multiple dose-escalation clinical trials showing better biological control of PSA,
        the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost
        in relation to the primary prostate lesion, considered to be the preferred site of neoplastic
        recurrence in prostate cancer.
  
        This leads to the first question, which concerns the identification of the dominant lesion
        and its precise delimitation. This last point is subject to variation between operators. A
        retrospective cohort from the Finistère region will therefore be used to develop a number of
        study points relating to :
  
        inter-operator contour variability
  
          -  Factors influencing contour
  
          -  Impact of contour variability on dosimetry
  
          -  Automatic segmentation
  Following the major technological and scientific advances in external radiotherapy in recent
        decades, thanks to the use of three-dimensional conformal techniques combined with intensity
        modulation, image-guided radiotherapy has enabled radiotherapists to increase doses without
        increasing sequelae and complications, giving rise to the term "dose escalation".
  
        Following multiple dose-escalation clinical trials showing better biological control of PSA,
        the results of the latest phase 3 FLAME trial incorporated the notion of intraprostatic boost
        in relation to the primary prostate lesion, considered to be the preferred site of neoplastic
        recurrence in prostate cancer.
  
        One of the issues raised by such a study is the methodology used to contour the tumour
        lesion, an issue which concerns the whole field of radiotherapy. The reference imaging
        technique for diagnosing prostate cancer, and more specifically the dominant tumour lesion,
        is multiparametric Magnetic Resonance Imaging. This leads to the first question, which
        concerns the identification of the dominant lesion and its precise delimitation. This last
        point is subject to variation between operators. A retrospective cohort from the Finistère
        region will therefore be used to develop a number of study points relating to :
  
        inter-operator contour variability
  
          -  Factors influencing contour
  
          -  Impact of contour variability on dosimetry
  
          -  Automatic segmentation
  observational model: Cohort
  time perspective: Retrospective
  measure: Inter-observer variability
  time frame: through study completion, an average of 6 months
  description: The main criterion for judging inter-observer variability is the spatial overlap of contours on mpMRI, represented by the DICE similarity coefficient, which ranges from 0 to 1, where 1 represents zero variability between contours of the same lesion.
  measure: Clinical factors influencing inter-observer variability.
  time frame: through study completion, an average of 6 months
  description: Subgroup analysis of radio-clinical-histological factors likely to influence inter-observer variability.
  measure: Assessing inter-sequence reproducibility
  time frame: through study completion, an average of 6 months
  description: Assessing inter-sequence reproducibility
  measure: Dosimetric impact of Inter-observer variability
  time frame: through study completion, an average of 6 months
  description: The influence of variability on dosimetry in IMRT/VMAT conformal radiotherapy.
  measure: Automatic segmentation of prostatic tumors
  time frame: through study completion, an average of 6 months
  description: Contour variability using a deep-learning automated segmentation technique, with and without implementation of factors identified as impacting contour in manual technique.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Vincent Bourbonne, MD, PhD
  role: Principal Investigator
  affiliation: Radiation Oncology Department, Brest University Hospital
  last name: Vincent BOURBONNE, MD, PhD
  phone: +33298223398
  email: vincent.bourbonne@chu-brest.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: Yes
  ipd description: All collected data that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: Data will be available beginning three years and ending fifteen years following the final study report completion
  ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement