<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/NCT03754569</url>
  </required_header>
  <id_info>
    <org_study_id>K171203J</org_study_id>
    <nct_id>NCT03754569</nct_id>
  </id_info>
  <brief_title>Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer</brief_title>
  <acronym>MicroPCI</acronym>
  <official_title>Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 objective of the cytoreductive surgery carried out for the management of ovarian cancers&#xD;
      is to obtain a complete macroscopic cytoreduction. This means that all visible peritoneal&#xD;
      metastases must be resected. The peritoneum is the most frequent site of recurrence after&#xD;
      initial management. There is no data on the existence, prevalence of microscopic peritoneal&#xD;
      metastases. It nevertheless represents a therapeutic target (intraperitoneal chemotherapy).&#xD;
      The main objective is the demonstration of microscopic peritoneal metastases in&#xD;
      macroscopically healthy peritoneum after complete macroscopic cytoreductive surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Understanding biology and progression mechanisms of peritoneal metastases (PM) of epithelial&#xD;
      ovarian cancer (EOC) is a cornerstone in the knowledge and the comprehensive management of&#xD;
      the disease, as PM will occur in the majority of patients. Indeed, the goal of cytoreductive&#xD;
      surgery (CRS) in these patients is to completely remove all visible peritoneal invasion&#xD;
      because the absence of residual disease after surgery is known to improve the prognosis.&#xD;
&#xD;
      Despite clinical remission after the completion of complete surgery and platinum-based&#xD;
      chemotherapy, 60% of patient develop peritoneal recurrence. This suggests that microscopic&#xD;
      lesions may be present that are not eradicated by surgery, not controlled by systemic&#xD;
      chemotherapy and that may be one of the mechanisms leading to peritoneal recurrence.&#xD;
      Peritoneal carcinomatosis is responsible for the greatest morbidity and mortality in women&#xD;
      with EOC.&#xD;
&#xD;
      There are very few studies in the literature on microscopic peritoneal involvement in EOC,&#xD;
      its detection and potential role in the progression of cancer. The peritoneum should be&#xD;
      considered an organ in its own right and the surgeon must treat peritoneal metastases with&#xD;
      the intent to cure. To follow the recommendations, this microscopic disease must be managed,&#xD;
      because complete CRS is now a skill that can be mastered skill and its uses is a validated&#xD;
      guideline. Moreover, &quot;complete CRS&quot; should be defined as &quot;without macroscopic residual&#xD;
      disease&quot; thus highlighting the presence of microscopic disease.&#xD;
&#xD;
      The goal of this study is to add scientific evidence for the existence of Microscopic&#xD;
      Peritoneal Metastases (mPM) and to justify the need for additional diagnostic and therapeutic&#xD;
      approaches.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">July 10, 2019</completion_date>
  <primary_completion_date type="Actual">July 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of microscopic peritoneal metastases on pathological examination of peritoneal biopsies after complete macroscopic cytoreductive surgery for epithelial ovarian cancer.</measure>
    <time_frame>one year</time_frame>
    <description>Random peritoneal biopsies in apparently healthy peritoneum, will be performed at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer. If peritoneal metastases are identified on this sample, they will be the subject of a detailed morphological description.&#xD;
Presence of microscopic peritoneal metastases will be measured (µm) using light microscope on HE slides from formalin fixed paraffin embedded tissues, by two different expert pathologists</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Expression of folate receptor by microscopic peritoneal metastases and comparison with primary tumor</measure>
    <time_frame>one year</time_frame>
    <description>Expression of folate receptor will measured by immuno-histo-chemistry. The intensity of the expression will be evaluated using semiquantitative method.&#xD;
Expression of folate receptor by microscopic peritoneal metastases will be assessed using immunohistochemistry with mouse monoclonal NCL-L-FRalpha antibody (Leica Biosystems). Expression will be quantified with a light microscope, using H-score according to the following formula : H-score = [1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)].</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Epithelial Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Peritoneal biopsies</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will perform at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer random peritoneal biopsies in apparently healthy peritoneum in order to assess the presence of microscopic peritoneal metastases</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Peritoneal biopsies after complete macroscopic cytoreduction</intervention_name>
    <description>We will perform at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer random peritoneal biopsies in apparently healthy peritoneum in order to assess the presence of microscopic peritoneal metastases</description>
    <arm_group_label>Peritoneal biopsies</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years-old, French nationality&#xD;
&#xD;
          -  with epithelial ovarian or tubal cancer&#xD;
&#xD;
          -  Complete macroscopic cytoreductive surgery (CC-0) regardless of the sequence compared&#xD;
             to chemotherapy.&#xD;
&#xD;
          -  Patient giving express consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Borderline ovarian tumor&#xD;
&#xD;
          -  Incomplete cytoreductive surgery&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Major under guardianship / trusteeship,&#xD;
&#xD;
          -  Not insured&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henri M AZAIS, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>October 18, 2019</last_update_submitted>
  <last_update_submitted_qc>October 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ovarian</keyword>
  <keyword>peritoneal</keyword>
  <keyword>recurrences</keyword>
  <keyword>surgery</keyword>
  <keyword>cancer</keyword>
  <keyword>metastases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <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/NCT03754569
org study id: K171203J
nct id: NCT03754569
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the cytoreductive surgery carried out for the management of ovarian cancers
      is to obtain a complete macroscopic cytoreduction. This means that all visible peritoneal
      metastases must be resected. The peritoneum is the most frequent site of recurrence after
      initial management. There is no data on the existence, prevalence of microscopic peritoneal
      metastases. It nevertheless represents a therapeutic target (intraperitoneal chemotherapy).
      The main objective is the demonstration of microscopic peritoneal metastases in
      macroscopically healthy peritoneum after complete macroscopic cytoreductive surgery.
Understanding biology and progression mechanisms of peritoneal metastases (PM) of epithelial
      ovarian cancer (EOC) is a cornerstone in the knowledge and the comprehensive management of
      the disease, as PM will occur in the majority of patients. Indeed, the goal of cytoreductive
      surgery (CRS) in these patients is to completely remove all visible peritoneal invasion
      because the absence of residual disease after surgery is known to improve the prognosis.

      Despite clinical remission after the completion of complete surgery and platinum-based
      chemotherapy, 60% of patient develop peritoneal recurrence. This suggests that microscopic
      lesions may be present that are not eradicated by surgery, not controlled by systemic
      chemotherapy and that may be one of the mechanisms leading to peritoneal recurrence.
      Peritoneal carcinomatosis is responsible for the greatest morbidity and mortality in women
      with EOC.

      There are very few studies in the literature on microscopic peritoneal involvement in EOC,
      its detection and potential role in the progression of cancer. The peritoneum should be
      considered an organ in its own right and the surgeon must treat peritoneal metastases with
      the intent to cure. To follow the recommendations, this microscopic disease must be managed,
      because complete CRS is now a skill that can be mastered skill and its uses is a validated
      guideline. Moreover, "complete CRS" should be defined as "without macroscopic residual
      disease" thus highlighting the presence of microscopic disease.

      The goal of this study is to add scientific evidence for the existence of Microscopic
      Peritoneal Metastases (mPM) and to justify the need for additional diagnostic and therapeutic
      approaches.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Identification of microscopic peritoneal metastases on pathological examination of peritoneal biopsies after complete macroscopic cytoreductive surgery for epithelial ovarian cancer.
time frame: one year
description: Random peritoneal biopsies in apparently healthy peritoneum, will be performed at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer. If peritoneal metastases are identified on this sample, they will be the subject of a detailed morphological description.
Presence of microscopic peritoneal metastases will be measured (µm) using light microscope on HE slides from formalin fixed paraffin embedded tissues, by two different expert pathologists
measure: Expression of folate receptor by microscopic peritoneal metastases and comparison with primary tumor
time frame: one year
description: Expression of folate receptor will measured by immuno-histo-chemistry. The intensity of the expression will be evaluated using semiquantitative method.
Expression of folate receptor by microscopic peritoneal metastases will be assessed using immunohistochemistry with mouse monoclonal NCL-L-FRalpha antibody (Leica Biosystems). Expression will be quantified with a light microscope, using H-score according to the following formula : H-score = [1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)].
arm group label: Peritoneal biopsies
arm group type: Experimental
description: We will perform at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer random peritoneal biopsies in apparently healthy peritoneum in order to assess the presence of microscopic peritoneal metastases
intervention type: Procedure
intervention name: Peritoneal biopsies after complete macroscopic cytoreduction
description: We will perform at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer random peritoneal biopsies in apparently healthy peritoneum in order to assess the presence of microscopic peritoneal metastases
arm group label: Peritoneal biopsies
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Henri M AZAIS, MD PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: Undecided