<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/NCT03777943</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2017/0784</org_study_id>
    <nct_id>NCT03777943</nct_id>
  </id_info>
  <brief_title>Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis</brief_title>
  <acronym>MMT</acronym>
  <official_title>Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Belgian Federation Against Cancer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</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 goal of this project is to investigate the extent and role of mesothelial - mesenchymal&#xD;
      transition (MMT) and cancer associated fibroblasts (CAFs) in the pathogenesis of colorectal&#xD;
      peritoneal carcinomatosis (PC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">March 28, 2022</completion_date>
  <primary_completion_date type="Actual">March 28, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Immunohistochemistry (IHC) analysis</measure>
    <time_frame>Within 6 months after collection of the samples</time_frame>
    <description>Extensive IHC analysis will be performed including CD44, integrins, ICAM-1, hyaluronate, and VCAM-1 (adhesion molecules); calretinin, mesothelin, WT1, cytokeratins and E-cadherin (mesothelial markers); α-SMA, FAP and podoplanin (CAF specific markers); PDGF, VEGF and EDGF (angiogenesis related markers)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra-tumoral versus peritoneal vascularity</measure>
    <time_frame>Within 6 months after collection of the samples</time_frame>
    <description>Vacularity will be assed using chalkley counts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laser capture microdisssection (LCM) followed by gene expression analysis</measure>
    <time_frame>Within 12 months after collection of the samples</time_frame>
    <description>Different cell types (mesothelial cells, submesothelial resident fibroblasts, CAFs) will be isolated using LCM, followed by gene expression analysis</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Peritoneal Carcinomatosis</condition>
  <arm_group>
    <arm_group_label>Cytoreductive surgery (CRS)</arm_group_label>
    <description>In patients presenting with colorectal peritoneal carcinomatosis, peritoneal tissue will be sampled during surgery at 4 different locations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sampling peritoneal tissue</intervention_name>
    <description>Resection specimen will be obtained during CRS from normal peritoneum at a distance, normal peritoneum close to a peritoneal metastasis, miliary peritoneal carcinomatosis, and established peritoneal carcinomatosis.</description>
    <arm_group_label>Cytoreductive surgery (CRS)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting with colorectal peritoneal carcinomatosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Patients presenting with colorectal peritoneal carcinomatosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Psychiatric pathology capable of affecting comprehension and judgment faculty&#xD;
&#xD;
          -  HIPEC (hyperthermic intraperitoneal chemotherapy) or PIPAC (pressurized&#xD;
             intraperitoneal aerosol chemotherapy) in the past&#xD;
&#xD;
          -  Abdominal radiation treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 9, 2022</last_update_submitted>
  <last_update_submitted_qc>December 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Ghent</investigator_affiliation>
    <investigator_full_name>GIHeelkunde</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Peritoneal 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/NCT03777943
org study id: EC/2017/0784
nct id: NCT03777943
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this project is to investigate the extent and role of mesothelial - mesenchymal
      transition (MMT) and cancer associated fibroblasts (CAFs) in the pathogenesis of colorectal
      peritoneal carcinomatosis (PC).
observational model: Other
time perspective: Prospective
measure: Immunohistochemistry (IHC) analysis
time frame: Within 6 months after collection of the samples
description: Extensive IHC analysis will be performed including CD44, integrins, ICAM-1, hyaluronate, and VCAM-1 (adhesion molecules); calretinin, mesothelin, WT1, cytokeratins and E-cadherin (mesothelial markers); α-SMA, FAP and podoplanin (CAF specific markers); PDGF, VEGF and EDGF (angiogenesis related markers)
measure: Intra-tumoral versus peritoneal vascularity
time frame: Within 6 months after collection of the samples
description: Vacularity will be assed using chalkley counts
measure: Laser capture microdisssection (LCM) followed by gene expression analysis
time frame: Within 12 months after collection of the samples
description: Different cell types (mesothelial cells, submesothelial resident fibroblasts, CAFs) will be isolated using LCM, followed by gene expression analysis
arm group label: Cytoreductive surgery (CRS)
description: In patients presenting with colorectal peritoneal carcinomatosis, peritoneal tissue will be sampled during surgery at 4 different locations.
intervention type: Procedure
intervention name: Sampling peritoneal tissue
description: Resection specimen will be obtained during CRS from normal peritoneum at a distance, normal peritoneum close to a peritoneal metastasis, miliary peritoneal carcinomatosis, and established peritoneal carcinomatosis.
arm group label: Cytoreductive surgery (CRS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Ghent
investigator full name: GIHeelkunde
investigator title: Principle investigator
mesh term: Carcinoma
mesh term: Peritoneal Neoplasms
sharing ipd: No