<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/NCT03268876</url>
  </required_header>
  <id_info>
    <org_study_id>2017/941</org_study_id>
    <nct_id>NCT03268876</nct_id>
  </id_info>
  <brief_title>The INFLUENCE of Cytoreduction on PRO in EOC</brief_title>
  <acronym>INFLUENCE</acronym>
  <official_title>The INFLUENCE of Cytoreduction on Patient Reported Outcomes in Patients With Epithelial Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sorlandet Hospital HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Haukeland University Hospital</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>
      Based on an improved understanding of how the extent of successful cytoreduction is&#xD;
      influenced both by inherent tumor biological characteristics as well as the aggressiveness of&#xD;
      the surgical approach this project aims to better define the value of cytoreduction and to&#xD;
      use the knowledge gained to develop more individualized therapy and follow-up. This will be&#xD;
      achieved through a translational biomedical research approach. Due to the research group's&#xD;
      traditions clinical phenotyping, biomarker identification, and clinical trials will be the&#xD;
      focus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will be recruited at their follow-up appointment after their surgery. At this&#xD;
      consultation the patient will be informed about the final diagnosis and extent of disease and&#xD;
      a plan for their further chemotherapeutic treatment will be developed. All patients will be&#xD;
      offered carboplatin AUC 5 and paclitaxel 175mg/m2 q3w for 6 cycles [+ bevacizumab 7.5mg/kg&#xD;
      q3w for 18 cycles in high-risk women of recurrence (IIIc not maximal debulked with a rest&#xD;
      tumor of &gt;1 cm2 and stage IV)]. In they fulfill the inclusion criteria and agree the inform&#xD;
      consent formula will be signed. During the screening period the study team will secure that&#xD;
      the necessary information needed is available and study specific test and analysis will be&#xD;
      undertaken. After inclusion the study specific consultations will be scheduled coinciding&#xD;
      with the patient regular appointments for treatment and follow-up. The patients will be&#xD;
      followed at predetermined time points (after finalizing the chemotherapy; and every 3 months&#xD;
      thereafter for 2 years).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 3, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">February 28, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Global Health Score</measure>
    <time_frame>2 years</time_frame>
    <description>Is there a relationship between QOL score and immunologic profiling in biological samples?</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Epithelial Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Epithelial ovarial cancer</arm_group_label>
    <description>Patients primary treated with primary surgery for advanced epithelial ovarian cancer (&gt; stage IIa) at the participating institutions will be asked to participate.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine and tumor biopsies&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients primary treated with primary surgery for advanced epithelial ovarian cancer at the&#xD;
        participating institutions will be asked to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Epithelial ovarian cancer&#xD;
&#xD;
          -  Stage &gt; II&#xD;
&#xD;
          -  ECOG &lt; II&#xD;
&#xD;
          -  Treated with primary surgery followed by chemotherapy&#xD;
&#xD;
          -  Willing to participate and to sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years old&#xD;
&#xD;
          -  Borderline and non-epithelial ovarian tumors&#xD;
&#xD;
          -  Stage &lt; II&#xD;
&#xD;
          -  Advanced ovarian cancer submitted to neoadjuvant chemotherapy&#xD;
&#xD;
          -  ECOG 3-4&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe cardiopulmonary disease&#xD;
&#xD;
          -  Patients participating in QoL intervention studies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Line Bjørge, MD, PhD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helse-Bergen HF</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Line Bjørge, MD, PhD, MBA</last_name>
    <phone>+4755975000</phone>
    <email>line.bjorge@uib.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Grete Iversen, MD</last_name>
    <phone>+4755975000</phone>
    <email>gaiv@helse-bergen.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Line Bjørge, MD, PhD</last_name>
      <phone>+4755975000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sørlandet sykehus HF</name>
      <address>
        <city>Kristiansand</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stavanger University Hospital</name>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epithelial ovarian cancer</keyword>
  <keyword>Surgery</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03268876
org study id: 2017/941
nct id: NCT03268876
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Based on an improved understanding of how the extent of successful cytoreduction is
      influenced both by inherent tumor biological characteristics as well as the aggressiveness of
      the surgical approach this project aims to better define the value of cytoreduction and to
      use the knowledge gained to develop more individualized therapy and follow-up. This will be
      achieved through a translational biomedical research approach. Due to the research group's
      traditions clinical phenotyping, biomarker identification, and clinical trials will be the
      focus.
The patients will be recruited at their follow-up appointment after their surgery. At this
      consultation the patient will be informed about the final diagnosis and extent of disease and
      a plan for their further chemotherapeutic treatment will be developed. All patients will be
      offered carboplatin AUC 5 and paclitaxel 175mg/m2 q3w for 6 cycles [+ bevacizumab 7.5mg/kg
      q3w for 18 cycles in high-risk women of recurrence (IIIc not maximal debulked with a rest
      tumor of >1 cm2 and stage IV)]. In they fulfill the inclusion criteria and agree the inform
      consent formula will be signed. During the screening period the study team will secure that
      the necessary information needed is available and study specific test and analysis will be
      undertaken. After inclusion the study specific consultations will be scheduled coinciding
      with the patient regular appointments for treatment and follow-up. The patients will be
      followed at predetermined time points (after finalizing the chemotherapy; and every 3 months
      thereafter for 2 years).
observational model: Cohort
time perspective: Prospective
measure: Mean Global Health Score
time frame: 2 years
description: Is there a relationship between QOL score and immunologic profiling in biological samples?
arm group label: Epithelial ovarial cancer
description: Patients primary treated with primary surgery for advanced epithelial ovarian cancer (> stage IIa) at the participating institutions will be asked to participate.
Blood, urine and tumor biopsies
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 100 Years
last name: Line Bjørge, MD, PhD, MBA
role: Principal Investigator
affiliation: Helse-Bergen HF
last name: Line Bjørge, MD, PhD, MBA
phone: +4755975000
email: line.bjorge@uib.no
last name: Grete Iversen, MD
phone: +4755975000
email: gaiv@helse-bergen.no
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
country: Norway
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: Undecided