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/NCT05984875</url>
    </required_header>
    <id_info>
      <org_study_id>IOSI-GYNE-001</org_study_id>
      <nct_id>NCT05984875</nct_id>
    </id_info>
    <brief_title>The Immune Landscape of Epithelial Ovarian Cancer</brief_title>
    <acronym>IOSI-GYNE-001</acronym>
    <official_title>The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oncology Institute of Southern Switzerland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institute of Oncology Research</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Oncology Institute of Southern Switzerland</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>
        This is a single center prospective observational study to characterize the immune landscape&#xD;
        of newly diagnosed epithelial ovarian cancer (OC).&#xD;
  &#xD;
        Patients with newly diagnosed epithelial OC will be enrolled in 4 different cohorts: A) Newly&#xD;
        diagnosed high grade serous or endometroid OC undergoing primary debulking surgery; B) Newly&#xD;
        diagnosed high grade serous or endometroid OC undergoing neoadjuvant chemotherapy (NACT)&#xD;
        followed by interval debulking surgery; C) Rare subtypes of epithelial OC (low grade serous,&#xD;
        low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking&#xD;
        surgery; D) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear&#xD;
        cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. A&#xD;
        cohort of women undergoing adnexectomy for benign pathology will be enrolled (cohort E) for&#xD;
        comparative analysis.&#xD;
  &#xD;
        Enrolled patients will be asked to provide the following biological samples at specified time&#xD;
        points: archival and fresh tumor tissue, peripheral blood samples, rectal and vaginal swabs,&#xD;
        ascites (when present).&#xD;
  &#xD;
        The main aim of the study is to characterize the immune landscape of epithelial OC in tumor&#xD;
        tissue and peripheral blood and correlate the presence of myeloid-derived suppressive cells&#xD;
        (MDSCs) and other immune infiltrates and of the systemic immune response with progression&#xD;
        free interval (PFI) in epithelial OC.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 20, 2022</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 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>Characterization of the immune cells infiltrate</measure>
      <time_frame>At the time of diagnosis in the tumor tissue and on blood. For patients receiving chemotherapy, assessment on blood after cycle 3 and 6</time_frame>
      <description>Expression of multiple immune cell markers will be assessed in samples from different subtypes of epithelial ovarian cancer by flow cytometric analysis. Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To define the prognostic value of the immune cells infiltrate</measure>
      <time_frame>From diagnosis until disease progression or study termination, whichever will occur first</time_frame>
      <description>The prognostic value of the immune cell populations identified by flow cytometry will be evaluated by calculating the correlation coefficient between the percentage of the immune cell population and the progression-free interval.</description>
    </secondary_outcome>
    <number_of_groups>5</number_of_groups>
    <enrollment type="Anticipated">74</enrollment>
    <condition>Epithelial Ovarian Cancer</condition>
    <arm_group>
      <arm_group_label>A</arm_group_label>
      <description>Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>B</arm_group_label>
      <description>Newly diagnosed high grade serous or endometroid OC undergoing NACT followed by interval debulking surgery. This cohort also includes patients that will not be deemed suitable for interval debulking surgery following NACT</description>
    </arm_group>
    <arm_group>
      <arm_group_label>C</arm_group_label>
      <description>Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>D</arm_group_label>
      <description>Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. This cohort also includes patients with the selected histological subtypes that will not be deemed suitable to interval debulking surgery following NACT</description>
    </arm_group>
    <arm_group>
      <arm_group_label>E</arm_group_label>
      <description>Women undergoing adnexectomy for benign pathology</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Collection of tumor samples, blood and vaginal and rectal swabs</intervention_name>
      <description>The following biological samples will be collected at different time points, according to the specified cohort and after signing the inform consent form: tumor tissue (fresh and archival) or normal tissue (cohort E), ascites (when present), peripheral blood, rectal swab, vaginal swab.</description>
      <arm_group_label>A</arm_group_label>
      <arm_group_label>B</arm_group_label>
      <arm_group_label>C</arm_group_label>
      <arm_group_label>D</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with newly diagnosed epithelial ovarian cancer and subjects with bening&#xD;
          gynecological conditions requiring surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria cohort A-D:&#xD;
  &#xD;
            -  Suspicious diagnosis of epithelial ovarian cancer (subsequent histologically&#xD;
               confirmation required)&#xD;
  &#xD;
            -  Plan to undergo a surgical procedure for the management of epithelial ovarian cancer&#xD;
               or recurrent ovarian cancer previously treated with conventional treatment and&#xD;
               involved in the trial as group A-D&#xD;
  &#xD;
            -  ≥18 years old&#xD;
  &#xD;
            -  ECOG Performance Status ≤ 2&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Inclusion criteria cohort E:&#xD;
  &#xD;
            -  Indication for adnexectomy for a benign gynecological condition&#xD;
  &#xD;
            -  ≥18 years old&#xD;
  &#xD;
            -  ECOG Performance Status ≤ 2&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Exclusion criteria cohort A-E:&#xD;
  &#xD;
            -  Other active concomitant neoplasms that might confound the results of the planned&#xD;
               analysis.&#xD;
  &#xD;
            -  Ongoing active autoimmune disease requiring treatment or condition of immune&#xD;
               deficiency&#xD;
  &#xD;
            -  Ongoing chronic treatment with steroids or other immune suppressive agents at the time&#xD;
               of study entry&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ilaria Colombo, MD</last_name>
      <phone>+41764528823</phone>
      <email>ilaria.colombo@eoc.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>Oncology Institute of Southern Switzerland</name>
        <address>
          <city>Bellinzona</city>
          <zip>6500</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ilaria Colombo, MD</last_name>
        <phone>+41764528823</phone>
        <email>ilaria.colombo@eoc.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</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>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05984875
  org study id: IOSI-GYNE-001
  nct id: NCT05984875
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a single center prospective observational study to characterize the immune landscape
        of newly diagnosed epithelial ovarian cancer (OC).
  
        Patients with newly diagnosed epithelial OC will be enrolled in 4 different cohorts: A) Newly
        diagnosed high grade serous or endometroid OC undergoing primary debulking surgery; B) Newly
        diagnosed high grade serous or endometroid OC undergoing neoadjuvant chemotherapy (NACT)
        followed by interval debulking surgery; C) Rare subtypes of epithelial OC (low grade serous,
        low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking
        surgery; D) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear
        cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. A
        cohort of women undergoing adnexectomy for benign pathology will be enrolled (cohort E) for
        comparative analysis.
  
        Enrolled patients will be asked to provide the following biological samples at specified time
        points: archival and fresh tumor tissue, peripheral blood samples, rectal and vaginal swabs,
        ascites (when present).
  
        The main aim of the study is to characterize the immune landscape of epithelial OC in tumor
        tissue and peripheral blood and correlate the presence of myeloid-derived suppressive cells
        (MDSCs) and other immune infiltrates and of the systemic immune response with progression
        free interval (PFI) in epithelial OC.
  observational model: Cohort
  time perspective: Prospective
  measure: Characterization of the immune cells infiltrate
  time frame: At the time of diagnosis in the tumor tissue and on blood. For patients receiving chemotherapy, assessment on blood after cycle 3 and 6
  description: Expression of multiple immune cell markers will be assessed in samples from different subtypes of epithelial ovarian cancer by flow cytometric analysis. Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.
  measure: To define the prognostic value of the immune cells infiltrate
  time frame: From diagnosis until disease progression or study termination, whichever will occur first
  description: The prognostic value of the immune cell populations identified by flow cytometry will be evaluated by calculating the correlation coefficient between the percentage of the immune cell population and the progression-free interval.
  arm group label: A
  description: Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery
  arm group label: B
  description: Newly diagnosed high grade serous or endometroid OC undergoing NACT followed by interval debulking surgery. This cohort also includes patients that will not be deemed suitable for interval debulking surgery following NACT
  arm group label: C
  description: Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery
  arm group label: D
  description: Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. This cohort also includes patients with the selected histological subtypes that will not be deemed suitable to interval debulking surgery following NACT
  arm group label: E
  description: Women undergoing adnexectomy for benign pathology
  intervention type: Other
  intervention name: Collection of tumor samples, blood and vaginal and rectal swabs
  description: The following biological samples will be collected at different time points, according to the specified cohort and after signing the inform consent form: tumor tissue (fresh and archival) or normal tissue (cohort E), ascites (when present), peripheral blood, rectal swab, vaginal swab.
  arm group label: A
  arm group label: B
  arm group label: C
  arm group label: D
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ilaria Colombo, MD
  phone: +41764528823
  email: ilaria.colombo@eoc.ch
  facility: 
  status: Recruiting
  contact: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  sharing ipd: No