<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/NCT04507191</url>
  </required_header>
  <id_info>
    <org_study_id>R.20.07.957</org_study_id>
    <nct_id>NCT04507191</nct_id>
  </id_info>
  <brief_title>PDL1 in Ovarian High Grade Serous Carcinoma</brief_title>
  <official_title>Prognostic Value of PDL1 in Ovarian High Grade Serous Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Port Said University hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mansoura University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Port Said University hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the main purpose is to study the prognostic effect of PDL1 in ovarian cancer especially HGSC.&#xD;
      Therefore, in the present study the investigators analyzed the expression of PDL1in HGSC by&#xD;
      immunohistochemistry, and results were correlated to prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      this cross-sectional study on 54 specimens of primary ovarian high grade serous carcinoma&#xD;
      cases who attended to Oncology Centre, Mansoura University, Mansoura, Egypt in the period&#xD;
      from 2012 till 2019. The cases were chosen randomly. All clinicopathological data including&#xD;
      tumor stage (T), L.N metastases (N), metastasis (M), (FIGO) staging system, ascites,&#xD;
      recurrence, residual tumor, CEA level, CA125 level, and peritoneal deposits analyzed. The&#xD;
      investigator followed the clinical outcomes in the form of disease free survival (DFS) and&#xD;
      overall survival (OS). The mean duration of follow up will be 43.4 months. The OS were&#xD;
      calculated from the time of diagnosis to death. DFS is the time from the end of therapy to&#xD;
      first recurrence or metastases. the specimens were stained with PDL1 marker in pathology&#xD;
      department Port Said university.&#xD;
&#xD;
      Statistical analysis: Data was analyzed using SPSS software V.16. Continuous data was&#xD;
      presented in the form of mean (SD) or Median (min-max) according to the results of&#xD;
      Shapiro-Wilk testing for the assumptions of normal distributions of data. Categorical data&#xD;
      will be presented in the form of frequencies and percentages. Statistical significance will&#xD;
      be tested by Welch's t-test, or Mann-Whitney U for continuous data (with respect to presence&#xD;
      or absence of normal distribution of data). Also, chi square test or Fisher's Exact Test will&#xD;
      be performed for categorical data (with respect to the minimal expected values in the&#xD;
      contingencies tables). Correlations of different tumour markers will be calculated using&#xD;
      Spearman's rho Coefficient. Kaplan-Meier test was used to test for overall survival and&#xD;
      disease free survival of patients with respect to tumour expression of PDL1. Comparisons will&#xD;
      be done using Log Rank (Mantel-Cox). Significance level is set at 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2012</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number of slides stained positive to PDL1 marker</measure>
    <time_frame>7 years from 2012 to 2019</time_frame>
    <description>using immunohistochemical staining for PDL1 markers for all slides of cases with ovarian tumor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>correlation between PDL1 expression to clinicopathological parameters of ovarian high grade serous carcinoma</measure>
    <time_frame>7 years from 2012 to 2019</time_frame>
    <description>correlation between PDL1 expression to criteria as ascites, peritoneal nodules and metastasis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>correlation between PDL1 expression to prognosis of ovarian high grade serous carcinoma</measure>
    <time_frame>43.3 months</time_frame>
    <description>correlation between PDL1 expression to cancer free peroid</description>
  </other_outcome>
  <enrollment type="Actual">54</enrollment>
  <condition>Ovarian Cancer</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>immunohistochemical staining</intervention_name>
    <description>immunohistochemical staining of programmed death-ligand 1 (PDL1) marker</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patients diagnosed with primary serous ovarian cancer and subjected to staging&#xD;
        laparotomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients diagnosed with primary ovarian cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with metastatic ovarian cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine, Port Said University</name>
      <address>
        <city>Port Said</city>
        <zip>42511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Port Said University hospital</investigator_affiliation>
    <investigator_full_name>Mayada saad</investigator_full_name>
    <investigator_title>Lecturer of pathology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystadenocarcinoma, Serous</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/NCT04507191
org study id: R.20.07.957
nct id: NCT04507191
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
the main purpose is to study the prognostic effect of PDL1 in ovarian cancer especially HGSC.
      Therefore, in the present study the investigators analyzed the expression of PDL1in HGSC by
      immunohistochemistry, and results were correlated to prognosis.
this cross-sectional study on 54 specimens of primary ovarian high grade serous carcinoma
      cases who attended to Oncology Centre, Mansoura University, Mansoura, Egypt in the period
      from 2012 till 2019. The cases were chosen randomly. All clinicopathological data including
      tumor stage (T), L.N metastases (N), metastasis (M), (FIGO) staging system, ascites,
      recurrence, residual tumor, CEA level, CA125 level, and peritoneal deposits analyzed. The
      investigator followed the clinical outcomes in the form of disease free survival (DFS) and
      overall survival (OS). The mean duration of follow up will be 43.4 months. The OS were
      calculated from the time of diagnosis to death. DFS is the time from the end of therapy to
      first recurrence or metastases. the specimens were stained with PDL1 marker in pathology
      department Port Said university.

      Statistical analysis: Data was analyzed using SPSS software V.16. Continuous data was
      presented in the form of mean (SD) or Median (min-max) according to the results of
      Shapiro-Wilk testing for the assumptions of normal distributions of data. Categorical data
      will be presented in the form of frequencies and percentages. Statistical significance will
      be tested by Welch's t-test, or Mann-Whitney U for continuous data (with respect to presence
      or absence of normal distribution of data). Also, chi square test or Fisher's Exact Test will
      be performed for categorical data (with respect to the minimal expected values in the
      contingencies tables). Correlations of different tumour markers will be calculated using
      Spearman's rho Coefficient. Kaplan-Meier test was used to test for overall survival and
      disease free survival of patients with respect to tumour expression of PDL1. Comparisons will
      be done using Log Rank (Mantel-Cox). Significance level is set at 0.05.
observational model: Other
time perspective: Cross-Sectional
measure: number of slides stained positive to PDL1 marker
time frame: 7 years from 2012 to 2019
description: using immunohistochemical staining for PDL1 markers for all slides of cases with ovarian tumor
measure: correlation between PDL1 expression to clinicopathological parameters of ovarian high grade serous carcinoma
time frame: 7 years from 2012 to 2019
description: correlation between PDL1 expression to criteria as ascites, peritoneal nodules and metastasis
measure: correlation between PDL1 expression to prognosis of ovarian high grade serous carcinoma
time frame: 43.3 months
description: correlation between PDL1 expression to cancer free peroid
intervention type: Diagnostic Test
intervention name: immunohistochemical staining
description: immunohistochemical staining of programmed death-ligand 1 (PDL1) marker
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Port Said University hospital
investigator full name: Mayada saad
investigator title: Lecturer of pathology
mesh term: Cystadenocarcinoma, Serous
sharing ipd: Undecided