<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/NCT03798132</url>
  </required_header>
  <id_info>
    <org_study_id>SouthECI</org_study_id>
    <nct_id>NCT03798132</nct_id>
  </id_info>
  <brief_title>Peritoneal Carcinomatosis Extent Evaluation: Radiologic, Laparoscopic and Pathologic.</brief_title>
  <official_title>Imaging Evaluation of Peritoneal Carcinomatosis Extent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shimaa Abdalla Ahmed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>South Egypt Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      pathologically proved ovarian cancer patients that underwent contrast enhanced&#xD;
      abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be&#xD;
      included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker's&#xD;
      method, peritoneal carcinomatosis extent will be categorized into low, moderate and large.&#xD;
      Agreement in general and in each category between CT, laparoscopy, surgery and pathology will&#xD;
      be assessed using kappa agreement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      we will search medical records of primary ovarian cancer patients underwent CT abdomen,&#xD;
      laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent&#xD;
      by each modality.&#xD;
&#xD;
      Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total&#xD;
      PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of&#xD;
      peritoneal carcinomatosis was classified into 3 categories low if PCI &lt; 10, moderate if&#xD;
      10-20, and large if &gt;20.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">June 11, 2019</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>peritoneal carcinomatosis</measure>
    <time_frame>one year</time_frame>
    <description>Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>surgical decision making.</measure>
    <time_frame>one year</time_frame>
    <description>correlation of peritoneal carcinomatosis categorization with surgical decision</description>
  </secondary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Peritoneal Carcinomatosis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>laparoscopy</intervention_name>
    <description>evaluation of peritoneal carcinomatosis by laparoscopy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pathologically proved ovarian cancer patients recived cytoreductive surgery and underwent&#xD;
        preoperative CT and diagnostic laparoscopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:pathologically proved ovarian cancer patients underwent contrast&#xD;
        enhanced abdominopelvic CT and diagnostic laparoscopy before cytoreductive surgery -&#xD;
&#xD;
        Exclusion Criteria:recurrent ovarian cancer&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>South Egypt Cancer Institute</name>
      <address>
        <city>Assiut</city>
        <zip>11517</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shimaa Ahmed, Lecturer</last_name>
      <phone>01007653325</phone>
      <email>shimaaabdalla@aun.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17.</citation>
    <PMID>18801470</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>South Egypt Cancer Institute</investigator_affiliation>
    <investigator_full_name>Shimaa Abdalla Ahmed</investigator_full_name>
    <investigator_title>lecturer of radiodiagnosis</investigator_title>
  </responsible_party>
  <keyword>Ovarian Neoplasms, Laparoscopy, Cytoreduction Surgical Procedures.</keyword>
  <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>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/NCT03798132
org study id: SouthECI
nct id: NCT03798132
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
pathologically proved ovarian cancer patients that underwent contrast enhanced
      abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be
      included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker's
      method, peritoneal carcinomatosis extent will be categorized into low, moderate and large.
      Agreement in general and in each category between CT, laparoscopy, surgery and pathology will
      be assessed using kappa agreement.
we will search medical records of primary ovarian cancer patients underwent CT abdomen,
      laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent
      by each modality.

      Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total
      PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of
      peritoneal carcinomatosis was classified into 3 categories low if PCI < 10, moderate if
      10-20, and large if >20.
observational model: Cohort
time perspective: Retrospective
measure: peritoneal carcinomatosis
time frame: one year
description: Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement.
measure: surgical decision making.
time frame: one year
description: correlation of peritoneal carcinomatosis categorization with surgical decision
intervention type: Diagnostic Test
intervention name: laparoscopy
description: evaluation of peritoneal carcinomatosis by laparoscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17.
PMID: 18801470
responsible party type: Sponsor-Investigator
investigator affiliation: South Egypt Cancer Institute
investigator full name: Shimaa Abdalla Ahmed
investigator title: lecturer of radiodiagnosis
mesh term: Carcinoma
mesh term: Peritoneal Neoplasms
sharing ipd: Undecided